Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-10 @ 4:07 AM
Study NCT ID:
NCT03197935
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2017-06-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'C455861', 'term': 'pegfilgrastim'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of these secondary endpoints are descriptive in nature.'}}, 'adverseEventsModule': {'timeFrame': 'From the first study drug and up to study final analysis data cut off on 28 September 2022, up to approximately 62 months.', 'description': 'Safety population included participants who received any amount of any study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 167, 'seriousNumAtRisk': 167, 'deathsNumAffected': 28, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 162, 'seriousNumAtRisk': 164, 'deathsNumAffected': 16, 'seriousNumAffected': 59}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 80, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 89, 'numAffected': 64}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 46, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 123, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 141, 'numAffected': 65}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 64, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 74, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 117, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 110, 'numAffected': 74}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 189, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 218, 'numAffected': 108}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 48, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 70, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 105, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 40, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 66, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 86, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 94, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 35, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 55, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 28, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 53, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 63, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 44, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 64, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 67, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 60, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 35, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 33, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 36, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 37, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 24, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 61, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 76, 'numAffected': 50}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 49, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 86, 'numAffected': 51}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 36, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 33, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 46, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 86, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 42, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 48, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 45, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 65, 'numAffected': 58}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Polyneuropathy', 'stats': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Pneumonitis chemical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Renal infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Dermatomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute difference in pCR rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.50', 'ciLowerLimit': '5.91', 'ciUpperLimit': '27.10', 'pValueComment': '(one-sided)', 'groupDescription': 'Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020', 'description': 'Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (full population) is defined as all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0206', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in pCR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.50', 'ciLowerLimit': '4.17', 'ciUpperLimit': '34.83', 'pValueComment': '(one-sided)', 'groupDescription': 'Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020', 'description': 'Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell \\[IC\\] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.'}, {'type': 'SECONDARY', 'title': 'Event-Free Survival (EFS) in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.21', 'groupDescription': 'Stratified analysis. Strata are:\n\nTumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (full population) is defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.26', 'ciUpperLimit': '1.18', 'groupDescription': 'Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.'}, {'type': 'SECONDARY', 'title': 'Disease-Free Survival (DFS) in All Participants Who Undergo Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.30', 'groupDescription': 'Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From surgery and up to study final analysis data cut off on 28 September 2022.', 'description': 'Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (full population) is defined as all randomized participants. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS.'}, {'type': 'SECONDARY', 'title': 'Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.43', 'groupDescription': 'Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From surgery and up to study final analysis data cut off on 28 September 2022.', 'description': 'Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS in the Subpopulation of Participants with PD-L1-Positive Tumor Status.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.04', 'groupDescription': 'Stratified analysis. Strata are:\n\nTumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of OS. The analyses of this secondary endpoint are descriptive in nature.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (full population) is defined as all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.26', 'ciUpperLimit': '1.91', 'groupDescription': 'Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of this secondary endpoint are descriptive in nature.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.'}, {'type': 'SECONDARY', 'title': 'Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'title': 'GHS/QoL Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.45', 'groupId': 'OG000', 'lowerLimit': '73.47', 'upperLimit': '79.42'}, {'value': '79.24', 'groupId': 'OG001', 'lowerLimit': '76.34', 'upperLimit': '82.14'}]}]}, {'title': 'GHS/QoL Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.90', 'groupId': 'OG000', 'lowerLimit': '69.04', 'upperLimit': '74.76'}, {'value': '71.55', 'groupId': 'OG001', 'lowerLimit': '68.53', 'upperLimit': '74.57'}]}]}, {'title': 'GHS/QoL Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.30', 'groupId': 'OG000', 'lowerLimit': '62.25', 'upperLimit': '68.34'}, {'value': '62.65', 'groupId': 'OG001', 'lowerLimit': '58.94', 'upperLimit': '66.36'}]}]}, {'title': 'GHS/QoL Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.36', 'groupId': 'OG000', 'lowerLimit': '59.15', 'upperLimit': '65.58'}, {'value': '59.84', 'groupId': 'OG001', 'lowerLimit': '56.62', 'upperLimit': '63.07'}]}]}, {'title': 'GHS/QoL Cycle Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.37', 'groupId': 'OG000', 'lowerLimit': '56.87', 'upperLimit': '63.87'}, {'value': '53.60', 'groupId': 'OG001', 'lowerLimit': '49.71', 'upperLimit': '57.48'}]}]}, {'title': 'GHS/QoL Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.25', 'groupId': 'OG000', 'lowerLimit': '70.86', 'upperLimit': '77.65'}, {'value': '70.14', 'groupId': 'OG001', 'lowerLimit': '66.97', 'upperLimit': '73.31'}]}]}, {'title': 'GHS/QoL Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.50', 'groupId': 'OG000', 'lowerLimit': '73.39', 'upperLimit': '79.62'}, {'value': '73.57', 'groupId': 'OG001', 'lowerLimit': '70.92', 'upperLimit': '76.22'}]}]}, {'title': 'GHS/QoL Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.17', 'groupId': 'OG000', 'lowerLimit': '74.35', 'upperLimit': '79.99'}, {'value': '72.06', 'groupId': 'OG001', 'lowerLimit': '69.01', 'upperLimit': '75.11'}]}]}, {'title': 'GHS/QoL Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.62', 'groupId': 'OG000', 'lowerLimit': '72.54', 'upperLimit': '78.69'}, {'value': '72.18', 'groupId': 'OG001', 'lowerLimit': '69.18', 'upperLimit': '75.17'}]}]}, {'title': 'GHS/QoL Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.22', 'groupId': 'OG000', 'lowerLimit': '72.22', 'upperLimit': '78.22'}, {'value': '70.56', 'groupId': 'OG001', 'lowerLimit': '67.09', 'upperLimit': '74.03'}]}]}, {'title': 'GHS/QoL Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.98', 'groupId': 'OG000', 'lowerLimit': '73.17', 'upperLimit': '78.79'}, {'value': '71.93', 'groupId': 'OG001', 'lowerLimit': '68.53', 'upperLimit': '75.32'}]}]}, {'title': 'GHS/QoL Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.84', 'groupId': 'OG000', 'lowerLimit': '72.93', 'upperLimit': '78.75'}, {'value': '72.40', 'groupId': 'OG001', 'lowerLimit': '69.27', 'upperLimit': '75.54'}]}]}, {'title': 'GHS/QoL Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.72', 'groupId': 'OG000', 'lowerLimit': '71.35', 'upperLimit': '78.08'}, {'value': '72.87', 'groupId': 'OG001', 'lowerLimit': '69.67', 'upperLimit': '76.06'}]}]}, {'title': 'GHS/QoL Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.79', 'groupId': 'OG000', 'lowerLimit': '71.61', 'upperLimit': '77.97'}, {'value': '71.19', 'groupId': 'OG001', 'lowerLimit': '67.65', 'upperLimit': '74.43'}]}]}, {'title': 'GHS/QoL Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '71.85', 'upperLimit': '78.15'}, {'value': '74.07', 'groupId': 'OG001', 'lowerLimit': '71.08', 'upperLimit': '77.06'}]}]}, {'title': 'GHS/QoL Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.70', 'groupId': 'OG000', 'lowerLimit': '74.70', 'upperLimit': '80.71'}, {'value': '74.93', 'groupId': 'OG001', 'lowerLimit': '71.69', 'upperLimit': '78.16'}]}]}, {'title': 'GHS/QoL Study Drug Completion/ Early Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.38', 'groupId': 'OG000', 'lowerLimit': '72.18', 'upperLimit': '78.59'}, {'value': '72.51', 'groupId': 'OG001', 'lowerLimit': '68.96', 'upperLimit': '76.05'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.97', 'groupId': 'OG000', 'lowerLimit': '73.87', 'upperLimit': '80.07'}, {'value': '72.65', 'groupId': 'OG001', 'lowerLimit': '69.33', 'upperLimit': '75.98'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.93', 'groupId': 'OG000', 'lowerLimit': '71.28', 'upperLimit': '78.59'}, {'value': '75.61', 'groupId': 'OG001', 'lowerLimit': '72.09', 'upperLimit': '79.14'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '71.32', 'upperLimit': '76.68'}, {'value': '75.19', 'groupId': 'OG001', 'lowerLimit': '71.78', 'upperLimit': '78.60'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.15', 'groupId': 'OG000', 'lowerLimit': '71.66', 'upperLimit': '78.64'}, {'value': '74.87', 'groupId': 'OG001', 'lowerLimit': '71.13', 'upperLimit': '78.60'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.39', 'groupId': 'OG000', 'lowerLimit': '72.29', 'upperLimit': '80.48'}, {'value': '75.60', 'groupId': 'OG001', 'lowerLimit': '72.01', 'upperLimit': '79.18'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.31', 'groupId': 'OG000', 'lowerLimit': '74.89', 'upperLimit': '81.73'}, {'value': '74.46', 'groupId': 'OG001', 'lowerLimit': '70.55', 'upperLimit': '78.37'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.33', 'groupId': 'OG000', 'lowerLimit': '74.08', 'upperLimit': '82.59'}, {'value': '73.50', 'groupId': 'OG001', 'lowerLimit': '68.56', 'upperLimit': '78.43'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.63', 'groupId': 'OG000', 'lowerLimit': '74.53', 'upperLimit': '82.73'}, {'value': '76.93', 'groupId': 'OG001', 'lowerLimit': '71.85', 'upperLimit': '82.01'}]}]}, {'title': 'GHS/QoL Survival Follow-Up Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '-259.32', 'upperLimit': '375.99'}, {'value': '63.10', 'groupId': 'OG001', 'lowerLimit': '47.77', 'upperLimit': '78.42'}]}]}, {'title': 'Physical Functioning Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.03', 'groupId': 'OG000', 'lowerLimit': '87.82', 'upperLimit': '92.24'}, {'value': '90.85', 'groupId': 'OG001', 'lowerLimit': '88.53', 'upperLimit': '93.17'}]}]}, {'title': 'Physical Functioning Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.50', 'groupId': 'OG000', 'lowerLimit': '80.79', 'upperLimit': '86.21'}, {'value': '84.93', 'groupId': 'OG001', 'lowerLimit': '82.55', 'upperLimit': '87.31'}]}]}, {'title': 'Physical Functioning Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.33', 'groupId': 'OG000', 'lowerLimit': '75.19', 'upperLimit': '81.48'}, {'value': '77.29', 'groupId': 'OG001', 'lowerLimit': '74.04', 'upperLimit': '80.54'}]}]}, {'title': 'Physical Functioning Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.42', 'groupId': 'OG000', 'lowerLimit': '67.06', 'upperLimit': '73.77'}, {'value': '69.02', 'groupId': 'OG001', 'lowerLimit': '65.52', 'upperLimit': '72.51'}]}]}, {'title': 'Physical Functioning Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.91', 'groupId': 'OG000', 'lowerLimit': '64.18', 'upperLimit': '71.65'}, {'value': '64.27', 'groupId': 'OG001', 'lowerLimit': '60.40', 'upperLimit': '68.13'}]}]}, {'title': 'Physical Functioning Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.49', 'groupId': 'OG000', 'lowerLimit': '76.38', 'upperLimit': '82.60'}, {'value': '78.01', 'groupId': 'OG001', 'lowerLimit': '74.81', 'upperLimit': '81.20'}]}]}, {'title': 'Physical Functioning Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.73', 'groupId': 'OG000', 'lowerLimit': '79.76', 'upperLimit': '85.71'}, {'value': '80.78', 'groupId': 'OG001', 'lowerLimit': '77.96', 'upperLimit': '83.60'}]}]}, {'title': 'Physical Functioning Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.15', 'groupId': 'OG000', 'lowerLimit': '82.75', 'upperLimit': '87.56'}, {'value': '81.75', 'groupId': 'OG001', 'lowerLimit': '78.59', 'upperLimit': '84.90'}]}]}, {'title': 'Physical Functioning Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.19', 'groupId': 'OG000', 'lowerLimit': '81.57', 'upperLimit': '86.81'}, {'value': '83.99', 'groupId': 'OG001', 'lowerLimit': '81.36', 'upperLimit': '86.62'}]}]}, {'title': 'Physical Functioning Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.78', 'groupId': 'OG000', 'lowerLimit': '82.16', 'upperLimit': '87.40'}, {'value': '83.88', 'groupId': 'OG001', 'lowerLimit': '81.21', 'upperLimit': '86.55'}]}]}, {'title': 'Physical Functioning Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 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[{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.68', 'groupId': 'OG000', 'lowerLimit': '77.46', 'upperLimit': '85.91'}, {'value': '76.98', 'groupId': 'OG001', 'lowerLimit': '71.47', 'upperLimit': '82.50'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.86', 'groupId': 'OG000', 'lowerLimit': '76.88', 'upperLimit': '86.85'}, {'value': '77.98', 'groupId': 'OG001', 'lowerLimit': '72.77', 'upperLimit': '83.18'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.47', 'groupId': 'OG000', 'lowerLimit': '73.62', 'upperLimit': '85.32'}, {'value': '80.09', 'groupId': 'OG001', 'lowerLimit': '75.03', 'upperLimit': '85.15'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.54', 'groupId': 'OG000', 'lowerLimit': '75.51', 'upperLimit': '87.56'}, {'value': '78.24', 'groupId': 'OG001', 'lowerLimit': '71.20', 'upperLimit': '85.28'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.48', 'groupId': 'OG000', 'lowerLimit': '79.88', 'upperLimit': '91.09'}, {'value': '81.64', 'groupId': 'OG001', 'lowerLimit': '75.23', 'upperLimit': '88.05'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'groupId': 'OG000', 'lowerLimit': '-128.44', 'upperLimit': '295.10'}, {'value': '76.19', 'groupId': 'OG001', 'lowerLimit': '-228.44', 'upperLimit': '195.10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).', 'unitOfMeasure': 'Score on a 0-100 scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'OG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'title': 'GHS/QoL Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.62', 'groupId': 'OG000', 'lowerLimit': '-7.89', 'upperLimit': '-1.36'}, {'value': '-7.91', 'groupId': 'OG001', 'lowerLimit': '-11.09', 'upperLimit': '-4.72'}]}]}, {'title': 'GHS/QoL Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.72', 'groupId': 'OG000', 'lowerLimit': '-16.34', 'upperLimit': '-9.10'}, {'value': '-17.07', 'groupId': 'OG001', 'lowerLimit': '-21.15', 'upperLimit': '-13.00'}]}]}, {'title': 'GHS/QoL Cycle 4 Day 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'groupId': 'OG000', 'lowerLimit': '-10.16', 'upperLimit': '-2.44'}, {'value': '-14.46', 'groupId': 'OG001', 'lowerLimit': '-19.69', 'upperLimit': '-9.24'}]}]}, {'title': 'Role Functioning Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.28', 'groupId': 'OG000', 'lowerLimit': '-11.77', 'upperLimit': '-2.80'}, {'value': '-13.82', 'groupId': 'OG001', 'lowerLimit': '-18.80', 'upperLimit': '-8.84'}]}]}, {'title': 'Role Functioning Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.63', 'groupId': 'OG000', 'lowerLimit': '-13.14', 'upperLimit': '-4.12'}, {'value': '-11.78', 'groupId': 'OG001', 'lowerLimit': '-16.96', 'upperLimit': '-6.60'}]}]}, {'title': 'Role Functioning Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.65', 'groupId': 'OG000', 'lowerLimit': '-9.70', 'upperLimit': '0.39'}, {'value': '-10.82', 'groupId': 'OG001', 'lowerLimit': '-15.56', 'upperLimit': '-6.07'}]}]}, {'title': 'Role Functioning Study Drug Completion/Early Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.46', 'groupId': 'OG000', 'lowerLimit': '-13.54', 'upperLimit': '-3.38'}, {'value': '-16.42', 'groupId': 'OG001', 'lowerLimit': '-21.64', 'upperLimit': '-11.21'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.98', 'groupId': 'OG000', 'lowerLimit': '-10.57', 'upperLimit': '-1.39'}, {'value': '-14.44', 'groupId': 'OG001', 'lowerLimit': '-19.35', 'upperLimit': '-9.53'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.67', 'groupId': 'OG000', 'lowerLimit': '-15.66', 'upperLimit': '-5.68'}, {'value': '-13.97', 'groupId': 'OG001', 'lowerLimit': '-18.84', 'upperLimit': '-9.10'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.61', 'groupId': 'OG000', 'lowerLimit': '-12.23', 'upperLimit': '-3.00'}, {'value': '-13.76', 'groupId': 'OG001', 'lowerLimit': '-18.45', 'upperLimit': '-9.08'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.66', 'groupId': 'OG000', 'lowerLimit': '-11.90', 'upperLimit': '-3.41'}, {'value': '-12.83', 'groupId': 'OG001', 'lowerLimit': '-18.13', 'upperLimit': '-7.53'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.03', 'groupId': 'OG000', 'lowerLimit': '-12.54', 'upperLimit': '-1.51'}, {'value': '-12.05', 'groupId': 'OG001', 'lowerLimit': '-17.15', 'upperLimit': '-6.95'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.96', 'groupId': 'OG000', 'lowerLimit': '-15.85', 'upperLimit': '-4.07'}, {'value': '-10.96', 'groupId': 'OG001', 'lowerLimit': '-16.19', 'upperLimit': '-5.72'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.72', 'groupId': 'OG000', 'lowerLimit': '-15.45', 'upperLimit': '-1.98'}, {'value': '-16.44', 'groupId': 'OG001', 'lowerLimit': '-23.12', 'upperLimit': '-9.75'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.65', 'groupId': 'OG000', 'lowerLimit': '-12.45', 'upperLimit': '1.16'}, {'value': '-12.56', 'groupId': 'OG001', 'lowerLimit': '-18.94', 'upperLimit': '-6.18'}]}]}, {'title': 'Role Functioning Survival Follow-Up Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'groupId': 'OG000', 'lowerLimit': '-228.44', 'upperLimit': '195.10'}, {'value': '-21.43', 'groupId': 'OG001', 'lowerLimit': '-47.70', 'upperLimit': '4.84'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30).', 'unitOfMeasure': 'Score on a 0-100 scale.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}, {'id': 'OG001', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Percentage of participants with at least one adverse event.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population is defined as all participants who received any dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Atezolizumab Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '142', 'spread': '54.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'categories': [{'measurements': [{'value': '189', 'spread': '64.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'categories': [{'measurements': [{'value': '207', 'spread': '77.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1', 'categories': [{'measurements': [{'value': '78.7', 'spread': '50.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1', 'categories': [{'measurements': [{'value': '204', 'spread': '62.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12 Day 1', 'categories': [{'measurements': [{'value': '267', 'spread': '81.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 16 Day 1', 'categories': [{'measurements': [{'value': '303', 'spread': '89.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)', 'description': 'Minimum observed serum atezolizumab concentration.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Atezolizumab Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '334', 'spread': '63.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 post dose (cycle length = 28 days)', 'description': 'Maximum observed atezolizumab concentration (Cmax).', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'classes': [{'title': 'Baseline evaluable participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-baseline evaluable participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately 20 months', 'description': 'Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The anti-drug antibodies (ADA)-evaluable population is defined as all participants treated with atezolizumab who have at least one post-baseline ADA result.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'FG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Death due to any cause', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.'}, {'id': 'BG001', 'title': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '50.1', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-24', 'size': 2953796, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-23T11:53', 'hasProtocol': True}, {'date': '2018-11-06', 'size': 636471, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-29T16:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2017-06-21', 'resultsFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-07', 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population', 'timeFrame': 'After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020', 'description': 'Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.'}, {'measure': 'Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System', 'timeFrame': 'After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020', 'description': 'Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell \\[IC\\] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.'}], 'secondaryOutcomes': [{'measure': 'Event-Free Survival (EFS) in All Participants', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.'}, {'measure': 'Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.'}, {'measure': 'Disease-Free Survival (DFS) in All Participants Who Undergo Surgery', 'timeFrame': 'From surgery and up to study final analysis data cut off on 28 September 2022.', 'description': 'Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.'}, {'measure': 'Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery', 'timeFrame': 'From surgery and up to study final analysis data cut off on 28 September 2022.', 'description': 'Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status.'}, {'measure': 'Overall Survival (OS) in All Participants', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.'}, {'measure': 'Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.'}, {'measure': 'Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).'}, {'measure': 'Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30).'}, {'measure': 'Percentage of Participants With at Least One Adverse Events (AEs)', 'timeFrame': 'From randomization and up to study final analysis data cut off on 28 September 2022.', 'description': 'Percentage of participants with at least one adverse event.'}, {'measure': 'Minimum Observed Serum Atezolizumab Concentration (Cmin)', 'timeFrame': 'Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)', 'description': 'Minimum observed serum atezolizumab concentration.'}, {'measure': 'Maximum Observed Serum Atezolizumab Concentration (Cmax)', 'timeFrame': 'Day 1 of Cycle 1 post dose (cycle length = 28 days)', 'description': 'Maximum observed atezolizumab concentration (Cmax).'}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab', 'timeFrame': 'Baseline up to approximately 20 months', 'description': 'Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Triple-negative Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40467898', 'type': 'DERIVED', 'citation': 'Mittendorf EA, Assaf ZJ, Harbeck N, Zhang H, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Qamra A, Dieterich M, Xu Y, Liste-Hermoso M, Shearer-Kang E, Molinero L, Chui SY, Barrios CH. Peri-operative atezolizumab in early-stage triple-negative breast cancer: final results and ctDNA analyses from the randomized phase 3 IMpassion031 trial. Nat Med. 2025 Jul;31(7):2397-2404. doi: 10.1038/s41591-025-03725-4. Epub 2025 Jun 4.'}, {'pmid': '32966830', 'type': 'DERIVED', 'citation': 'Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.'}, {'pmid': '32450725', 'type': 'DERIVED', 'citation': 'Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.'}]}, 'descriptionModule': {'briefSummary': 'This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 \\[anti-PD-L1\\] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically documented TNBC (negative human epidermal growth factor receptor 2 \\[HER2\\], estrogen receptor \\[ER\\], and progesterone receptor \\[PgR\\] status)\n* Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen\n* Primary breast tumor size of greater than (\\>) 2 centimeters (cm) by at least one radiographic or clinical measurement\n* Stage at presentation: cT2-cT4, cN0-cN3, cM0\n* Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment\n* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\\>=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans\n* Adequate hematologic and end-organ function\n* Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm\n* Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug\n\nExclusion criteria:\n\n* Prior history of invasive breast cancer\n* Stage 4 (metastatic) breast cancer\n* Prior systemic therapy for treatment and prevention of breast cancer\n* Previous therapy with anthracyclines or taxanes for any malignancy\n* History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy \\>5 years prior to diagnosis of current breast cancer\n* History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed \\>5 years prior to diagnosis of current breast cancer\n* Bilateral breast cancer\n* Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes\n* Axillary lymph node dissection prior to initiation of neoadjuvant therapy\n* History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death\n* Cardiopulmonary dysfunction\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells\n* Known allergy or hypersensitivity to the components of the formulations of atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or pegfilgrastim\n* Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus, and dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., participants with psoriatic arthritis are excluded)\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Positive human immunodeficiency virus (HIV) test at screening\n* Active hepatitis B and hepatitis C virus infection\n* Active tuberculosis\n* Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, except prophylactic antibiotics\n* Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study\n* Prior allogeneic stem cell or solid organ transplantation\n* Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications\n* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint-blockade therapies, including anti-cluster of differentiation 40 (anti-CD40), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medications during the study\n* History of cerebrovascular accident within 12 months prior to randomization\n* Pregnant or lactating, or intending to become pregnant during the study'}, 'identificationModule': {'nctId': 'NCT03197935', 'acronym': 'IMpassion031', 'briefTitle': 'A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'WO39392'}, 'secondaryIdInfos': [{'id': '2016-004734-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atezolizumab and Chemotherapy', 'description': 'Participants received atezolizumab (840 milligrams \\[mg\\]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter \\[mg/m\\^2\\]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.', 'interventionNames': ['Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody', 'Drug: Nab-paclitaxel', 'Drug: Doxorubicin', 'Drug: Cyclophosphamide', 'Drug: Filgrastim', 'Drug: Pegfilgrastim']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and Chemotherapy', 'description': 'Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m\\^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m\\^2) and cyclophosphamide (600 mg/m\\^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will be unblinded post-surgery and will continue to be followed.', 'interventionNames': ['Drug: Placebo', 'Drug: Nab-paclitaxel', 'Drug: Doxorubicin', 'Drug: Cyclophosphamide', 'Drug: Filgrastim', 'Drug: Pegfilgrastim']}], 'interventions': [{'name': 'Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody', 'type': 'DRUG', 'description': 'Atezolizumab was administered as per schedule described in respective arm.', 'armGroupLabels': ['Atezolizumab and Chemotherapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to atezolizumab was administered as per schedule described in respective arm.', 'armGroupLabels': ['Placebo and Chemotherapy']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': 'Nab-paclitaxel was administered as per schedule described in the arms.', 'armGroupLabels': ['Atezolizumab and Chemotherapy', 'Placebo and Chemotherapy']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin was administered as per schedule described in the arms.', 'armGroupLabels': ['Atezolizumab and Chemotherapy', 'Placebo and Chemotherapy']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide was administered as per schedule described in the arms.', 'armGroupLabels': ['Atezolizumab and Chemotherapy', 'Placebo and Chemotherapy']}, {'name': 'Filgrastim', 'type': 'DRUG', 'description': 'Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.', 'armGroupLabels': ['Atezolizumab and Chemotherapy', 'Placebo and Chemotherapy']}, {'name': 'Pegfilgrastim', 'type': 'DRUG', 'description': 'Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.', 'armGroupLabels': ['Atezolizumab and Chemotherapy', 'Placebo and Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06856', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwalk Hospital', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '30117', 'city': 'Carrollton', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital', 'geoPoint': {'lat': 33.58011, 'lon': -85.07661}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'HCA Midwest Division', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '07652', 'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital; Valley Medical Group', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37204', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Breast Center at One Hundred Oaks', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'The Center for Cancer and Blood Disorders - Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Cancer Care Northwest', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '6149', 'city': 'Bull Creek', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit', 'geoPoint': {'lat': -32.05625, 'lon': 115.86242}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires St-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'facility': 'Clinique Ste-Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Sint Augustinus Wilrijk', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '40050-410', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Santa Casa de Misericordia de Salvador', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '74605-070', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Hospital Araujo Jorge; Departamento de Ginecologia E Mama', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '38082-049', 'city': 'Uberaba', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'CETUS Hospital Dia Oncologia', 'geoPoint': {'lat': -19.74833, 'lon': -47.93194}}, {'zip': '80530-010', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Iop Instituto de Oncologia Do Parana', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '22290-160', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Clinicas Oncologicas Integradas - COI', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Sao Lucas - PUCRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '91350-200', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Nossa Senhora da Conceicao', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '01317-001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Sacre-Coeur Research Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1S 4L8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital du Saint Sacrement', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Hochwaldkrankenhaus', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '10367', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. 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