Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-25 @ 7:20 PM
Study NCT ID:
NCT04752332
Status:
TERMINATED
Last Update Posted:
2025-07-15
First Post:
2021-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland', 'Puerto Rico', 'Romania', 'Russia', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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': 'C000590451', 'term': 'abemaciclib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to inability to enroll study participants.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline Up To 890 Days', 'description': "All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.", 'eventGroups': [{'id': 'EG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 53, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 40, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 24, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 31, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 63, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 97, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Invasive Disease Free Survival (IDFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.'}, {'id': 'OG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}], 'timeFrame': 'Randomization to Recurrence or Death from Any Cause (up to 890 days)', 'description': 'IDFS, as defined by the STEEP System, is measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.'}, {'id': 'OG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}], 'timeFrame': 'Randomization to Death from Any Cause (up to 890 days)', 'description': 'OS is defined as the time from randomization until death from any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'type': 'SECONDARY', 'title': 'Distant Relapse-Free Survival (DRFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.'}, {'id': 'OG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}], 'timeFrame': 'Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)', 'description': 'DRFS is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.\n\nStudy was terminated early. Data was not collected for this outcome and outcome measures were not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Central Nervous System (CNS) Metastases as First Site of Disease Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.'}, {'id': 'OG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}], 'timeFrame': 'Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)', 'description': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.'}, {'id': 'OG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}], 'timeFrame': 'Cycle 1 up to 390 days', 'description': 'The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation will be applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.'}, {'id': 'OG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}], 'timeFrame': 'Cycle 1 up to 390 days', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which are anchored on a scale of 0 to 1 with a higher score representing better health status. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.'}, {'id': 'OG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}], 'timeFrame': 'Day 1 of Cycles 1-3 (Cycle = 28 days)', 'description': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '150 mg Abemaciclib + Endocrine Therapy (ET)', 'description': 'Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).'}, {'id': 'FG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'Received At Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Disease Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study Terminated by IRB/ERB', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was terminated early due to inability to enroll study participants. Data was not collected after termination and outcome measures were not assessed.', 'preAssignmentDetails': 'Completers were defined as participants who received abemaciclib and were allowed to stay on treatment in the study. Participants receiving placebo discontinued after the study was terminated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '150 mg Abemaciclib + ET', 'description': 'Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.'}, {'id': 'BG001', 'title': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.60', 'spread': '11.76', 'groupId': 'BG000'}, {'value': '49.70', 'spread': '11.17', 'groupId': 'BG001'}, {'value': '49.20', 'spread': '11.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 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{'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 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'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-14', 'size': 1117368, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-25T19:27', 'hasProtocol': True}, {'date': '2021-12-06', 'size': 4102541, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-25T19:29', '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': 111}}, 'statusModule': {'whyStopped': 'Study is terminated due to inability to enroll study participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03763604', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2021-02-11', 'resultsFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-26', 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Invasive Disease Free Survival (IDFS)', 'timeFrame': 'Randomization to Recurrence or Death from Any Cause (up to 890 days)', 'description': 'IDFS, as defined by the STEEP System, is measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization to Death from Any Cause (up to 890 days)', 'description': 'OS is defined as the time from randomization until death from any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'measure': 'Distant Relapse-Free Survival (DRFS)', 'timeFrame': 'Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)', 'description': 'DRFS is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.\n\nStudy was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'measure': 'Percentage of Participants With Central Nervous System (CNS) Metastases as First Site of Disease Recurrence', 'timeFrame': 'Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)', 'description': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'measure': 'Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score', 'timeFrame': 'Cycle 1 up to 390 days', 'description': 'The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation will be applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'measure': 'Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score', 'timeFrame': 'Cycle 1 up to 390 days', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which are anchored on a scale of 0 to 1 with a higher score representing better health status. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}, {'measure': 'Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib', 'timeFrame': 'Day 1 of Cycles 1-3 (Cycle = 28 days)', 'description': 'Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/5KSTmaOP3TBgL5LfSMwHYU', 'label': 'A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have confirmed HR+, HER2+ early invasive breast cancer without evidence of disease recurrence or distant metastases\n* Have undergone definitive surgery of the primary breast tumor(s)\n* Have tumor tissue from breast (preferred) or lymph node\n* Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care\n* Have completed approximately nine to 20 months of standard HER2-targeted therapy (neoadjuvant/adjuvant combined duration)\n* Have received one of the following eligible HER2-targeted adjuvant regimens AND be randomized within 12 weeks of completing the regimen:\n\n * For participants treated with neoadjuvant therapy and HER2-targeted therapy: A minimum of 4 cycles of T-DM1 in the adjuvant setting. NOTE: Participants may have received up to approximately 6 cycles of adjuvant trastuzumab prior to initiation of T-DM1. Additionally, participants may have switched to trastuzumab-based therapy (monotherapy or in combination with other HER2-targeted therapies) after 4 cycles of T-DM1\n * For participants who had definitive surgery prior to systemic therapy, a minimum of 4 cycles of adjuvant pertuzumab with trastuzumab.\n* Have high risk disease, defined by one of the following criteria:\n\n * Those who received neoadjuvant chemotherapy along with HER2-targeted treatment must have:\n\n * residual disease in at least one axillary lymph node, or\n * a residual tumor ≥ 5 cm, or\n * a residual tumor of any size that has direct extension to the chest wall and/or skin (ulceration or skin nodules).\n * Those who had definitive surgery prior to systemic therapy and completed adjuvant chemotherapy along with HER2-targeted therapies (trastuzumab and pertuzumab) must have\n\n * tumor involvement in ≥4 ipsilateral axillary lymph nodes, or\n * tumor involvement in 1 to 3 ipsilateral axillary lymph node(s) and histological Grade 3, or\n * primary invasive tumor size of ≥ 5 cm on pathological evaluation.\n\nExclusion Criteria:\n\n* Have breast cancer with any of the following features:\n\n * Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)\n * Pathological complete response from any prior early breast cancer treatments. Participants are required to have residual primary tumor and/or lymph node disease at the time of definitive surgery as indicated in inclusion criteria.\n * Inflammatory breast cancer\n* Have other medical conditions including:\n\n * Previous breast cancer (Exceptions: Ipsilateral ductal carcinoma in situ \\[DCIS\\] treated by locoregional therapy alone ≥5 years ago; contralateral DCIS treated by locoregional therapy at any time)\n * Other cancer being treated and/or not in complete remission within the last 5 years (Exceptions: Appropriately treated non-melanomatous skin cancer or carcinoma in situ of cervix, bladder, or colon)\n * Females who are pregnant or lactating\n * History of venous thromboembolism\n * Other serious medical conditions\n* Have previously received treatment with:\n\n * Any cyclin-dependent kinase (CDK)4 and CDK6 inhibitor\n * Prior adjuvant treatment with immunotherapy, tucatinib, neratinib, any investigational HER2 directed therapy, or T-DXd (DS8201) for treatment of breast cancer\n * Endocrine therapy (ET) (i.e., tamoxifen, raloxifene or aromatase inhibitor) for breast cancer prevention (without diagnosis of breast cancer)\n * Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard of care at study enrollment'}, 'identificationModule': {'nctId': 'NCT04752332', 'acronym': 'eMonarcHER', 'briefTitle': 'A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy', 'orgStudyIdInfo': {'id': '17384'}, 'secondaryIdInfos': [{'id': 'I3Y-MC-JPCW', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2020-004035-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '150 mg Abemaciclib + Endocrine Therapy (ET)', 'description': 'Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Standard Adjuvant ET']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + ET', 'description': 'Participants received placebo administered BID orally along with standard adjuvant ET.', 'interventionNames': ['Drug: Standard Adjuvant ET', 'Drug: Placebo']}], 'interventions': [{'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['LY2835219'], 'description': 'Administered orally.', 'armGroupLabels': ['150 mg Abemaciclib + Endocrine Therapy (ET)']}, {'name': 'Standard Adjuvant ET', 'type': 'DRUG', 'description': 'Administered according to label instructions.', 'armGroupLabels': ['150 mg Abemaciclib + Endocrine Therapy (ET)', 'Placebo + ET']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Placebo + ET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Palo Verde Cancer Specialists', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'TRIO-US (Translational Research in Oncology-US)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Millennium Oncology - Hollywood', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - North', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mt. 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