Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-02 @ 6:15 AM
Study NCT ID:
NCT00999804
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077341', 'term': 'Lapatinib'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rimawi@bcm.edu', 'phone': '7137981311', 'title': 'Dr. Mothaffar Rimawi', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 months', 'description': 'Adverse events experienced by participants will be collected and reported from initiation of study medication, throughout the study, and within 30 days of the last dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': '24-week Arm', 'description': 'Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks', 'otherNumAtRisk': 85, 'otherNumAffected': 61, 'seriousNumAtRisk': 85, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': '12-week Arm', 'description': 'Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks', 'otherNumAtRisk': 43, 'otherNumAffected': 26, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 54, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 11, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 46, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 51, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 22, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nusea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Elevated AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Breast infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathologic Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24-week Arm', 'description': 'Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}, {'id': 'OG001', 'title': '12-week Arm', 'description': 'Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}], 'classes': [{'title': 'pathologic complete response', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'non-complete pathologic response', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'proportion of pCR', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.25', 'estimateComment': 'No comparison is required between the 24 weeks arm and 12 weeks arm. The study is designed as the 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design and required 20 or more responses in the first 55 evaluable patients.', 'groupDescription': 'The study was planned to enroll 136 patients if the original cohort (n=90) was deemed successful. The 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design. The 12 weeks arm accrued as long as the 24 weeks arm is open.\n\nThe analysis of the first cohort indicated that 15 pCR were observed , which did not meet the required 20 or more responses. The accrual was closed early and the study has a total of 128 participants.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 or 24 week depending the arm assignment', 'description': "Pathologic complete response was defined as no residual invasive cancer in the breast, after 12 or 24 weeks of lapatinib/trastuzumab with or without endocrine therapy.\n\nThis outcome is based on patient's pathological report. We are not measuring the clinical response.\n\nParticipants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24-week Arm', 'description': 'Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}, {'id': 'OG001', 'title': '12-week Arm', 'description': 'Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'proportion of patients with AE', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.72', 'estimateComment': '61 out of 85 patients (72%) in the 24-week arm had at least 1 adverse events.', 'groupDescription': 'This outcome is to establish the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy. No comparison between the 2 arms is required.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 week or 24 weeks depending on arm assignment', 'description': 'the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who started the study treatment will be evaluable for safety analysis'}, {'type': 'SECONDARY', 'title': 'Total Pathologic Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24-week Arm', 'description': 'Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}, {'id': 'OG001', 'title': '12-week Arm', 'description': 'Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}], 'classes': [{'title': 'total complete pathologic response', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'not total complete pathologic response', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'proportion of tpCR in 24 weeks arm', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.1', 'groupDescription': 'No comparison between the two arms is required.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks or 24 weeks depending on arm assignment', 'description': 'pathologic complete response was defined as no residual invasive cancer in the breast and the axillary lymph nodes.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.'}, {'type': 'SECONDARY', 'title': 'Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24-week Arm', 'description': 'Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}, {'id': 'OG001', 'title': '12-week Arm', 'description': 'Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'proportion of CR+PR in 24 weeks arm', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.69', 'groupDescription': 'No comparison between the 2 arm is required for this study.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks or 24 weeks depending on arm assignment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participants were not evaluable for efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '24-week Arm', 'description': 'Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}, {'id': 'FG001', 'title': '12-week Arm', 'description': 'Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited between October 2011 and July 2014 at 10 study sites: Baylor College of Medicine, UAB, University of Chicago, Johns Hopkins, Duke, Indiana University, Vanderbilt, MDACC, DFCI, and Mayo Clinic.', 'preAssignmentDetails': 'Participants screened up to 28-day period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '24-week Arm', 'description': 'Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}, {'id': 'BG001', 'title': '12-week Arm', 'description': 'Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.\n\nLapatinib: 1000 mg by mouth daily\n\nLetrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)\n\nTrastuzumab: 6 mg/kg intravenously, every 3 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '80'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '88'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '128', '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': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2009-10-21', 'resultsFirstSubmitDate': '2015-12-29', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-19', 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response', 'timeFrame': '12 or 24 week depending the arm assignment', 'description': "Pathologic complete response was defined as no residual invasive cancer in the breast, after 12 or 24 weeks of lapatinib/trastuzumab with or without endocrine therapy.\n\nThis outcome is based on patient's pathological report. We are not measuring the clinical response.\n\nParticipants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '12 week or 24 weeks depending on arm assignment', 'description': 'the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy'}, {'measure': 'Total Pathologic Complete Response', 'timeFrame': '12 weeks or 24 weeks depending on arm assignment', 'description': 'pathologic complete response was defined as no residual invasive cancer in the breast and the axillary lymph nodes.'}, {'measure': 'Clinical Response', 'timeFrame': '12 weeks or 24 weeks depending on arm assignment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Locally Advanced Breast Cancer Neoadjuvant Endocrine'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31662331', 'type': 'DERIVED', 'citation': 'Rimawi MF, Niravath P, Wang T, Rexer BN, Forero A, Wolff AC, Nanda R, Storniolo AM, Krop I, Goetz MP, Nangia JR, Jiralerspong S, Pavlick A, Veeraraghavan J, De Angelis C, Gutierrez C, Schiff R, Hilsenbeck SG, Osborne CK; Translational Breast Cancer Research Consortium. TBCRC023: A Randomized Phase II Neoadjuvant Trial of Lapatinib Plus Trastuzumab Without Chemotherapy for 12 versus 24 Weeks in Patients with HER2-Positive Breast Cancer. Clin Cancer Res. 2020 Feb 15;26(4):821-827. doi: 10.1158/1078-0432.CCR-19-0851. Epub 2019 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer is the most common malignancy in the U.S. Targeted therapies such as tamoxifen have been revolutionary in reducing tumor recurrences and mortality in early breast cancer. Using this successful paradigm, there has been a continued search for other targeted biologic therapies directed at receptors with known potential for promoting tumor growth.\n\nThe estrogen receptor (ER) and/or the HER signaling pathways are the dominant drivers of cell proliferation and survival in the majority of human breast cancers. Molecular targets of these pathways provide the most effective therapies in appropriately selected patients. However, de novo and acquired resistance remain major obstacles to successful treatment, and understanding the molecular pathways responsible for this resistance would enable the discovery of new strategies to overcome it.\n\nThe superiority of multi-drug HER2-targeted therapy over single agent therapy has been demonstrated in the preclinical setting using mouse xenografts. Trastuzumab, pertuzumab, lapatinib, and gefitinib, represent a group of therapeutic agents that target the HER family by different molecular mechanisms. Used as single agents in the MCF7/HER2-18 xenograft model, these drugs restored or enhanced sensitivity to tamoxifen. However, tumor growth inhibition lasted only 2-3 months before resistance to treatments occurred. However, when gefitinib, a HER1 inhibitor, was added to the two-antibody (T+P) regimen to block signals from HER1 dimers, a complete disappearance of nearly all xenograft tumors was observed; moreover, there was evidence of complete tumor eradication in 50% of the mice. The combination of lapatinib + trastuzumab was also highly effective in eradication of tumor burden, with no evidence of re-growth after 200 days. These xenograft models demonstrate that multi-drug HER2-targeted therapy more effectively induces apoptosis and inhibits proliferation, thereby resulting in tumor regression. Furthermore, HER2 combination therapy appears to more effectively reduce levels of phosphorylated pAKT and MAPK, thus resulting in sustained tumor inhibition.', 'detailedDescription': 'Breast cancer cells have certain characteristics or traits--these traits are called biomarkers. There are three biomarkers that help doctors decide which treatment to give any given patient. These biomarkers are the estrogen receptor (ER), progesterone receptor (PgR), and HER2 protein. Breast cancer cells that have a large number of estrogen or progesterone receptors are called ER and/or PgR positive. Cancers that are ER and/or PgR positive use the hormones estrogen and progesterone to help them grow. Not all breast cancers are ER or PgR positive. Patients are being asked to take part in this study that have a special type of breast cancer called HER2 positive breast cancer. HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor-2 (HER2). HER2 is located on the outer surface of a cancer cell. The HER2 protein sends a signal to the inside of the cancer cells telling it to grow and divide.\n\nTwo medications that directly target this HER2 protein. One is called trastuzumab(Herceptin), and the other is called lapatinib (Tykerb). Both medications are FDA-approved for the treatment of women with HER2+ breast cancer. Each medication attaches to the protein so that it can no longer function. Once the protein stops working, the cancer cells can no longer make copies of themselves. This makes cancer shrink. Both drugs target HER2; however each drug works a little bit differently.\n\nSome patients respond better to Herceptin, and some patients respond better to Tykerb. Right now, we are not sure why some patients respond to one drug but do not respond to the other drug. One possibility is that in some patients, the HER2 protein finds another way to send its message to the inside of the cell (similar to a road detour). For example, when one path is "closed" because the drug is blocking it, the HER2 protein finds a different way to send its signal. We think that we can completely block the HER2 protein by giving patients both Tykerb and Herceptin.\n\nSome patients with HER positive breast cancer are also ER and/or PgR positive. Even after HER2 is completely blocked, these types of cancer cells can still grow by using the estrogen or progesterone receptor. If a patient is told they are ER and/or PgR positive, they will also take an anti-estrogen pill along with Tykerb and Herceptin. We think that we can stop cancer growth more completely by blocking both the HER2 protein and the ER/PR receptors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients must be female and at least 18 years of age.\n2. Signed informed consent.\n3. Locally advanced breast cancers are eligible. Locally advanced cancers must be of clinical and/or radiologic size \\>3 cm, or \\>2 cm with clinical evidence of axillary nodal involvement\\*. (If tumors are less than 3 cm, we will use the radiologically measured tumor size to determine if the tumor meets the minimal size requirements.)\n4. Patients must have histologically confirmed invasive mammary carcinoma that is HER2 overexpressing, defined as 3+ by immunohistochemistry, or a FISH/CEP ratio greater than 2.\n5. Negative serum pregnancy test (HCG) within 7 days of starting study drug, if of child-bearing potential.\n6. Kidney and liver function tests - all within 1.5 times the institutional upper limit of normal.\n7. Performance status (WHO/ECOG scale) 0-1 and life expectancy \\>6 months.\n8. No evidence of brain or leptomeningeal disease, or any other Stage IV disease.\n9. No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.\n\nExclusion Criteria:\n\n1. Patients with bilateral breast cancer.\n2. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.\n3. Severe underlying chronic illness or disease.\n4. Cardiomyopathy or baseline LVEF less than 50%.\n5. Other investigational drugs while on study.\n6. Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.\n7. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded\n8. Taking any lapatinib prohibited medication(s)\n9. Inability or unwillingness to comply with, or follow study procedures.\n10. Patients who have received any form of treatment for breast cancer within the past five years, including surgical resection, chemotherapy, endocrine therapy, or biologic therapy.\n11. Patients with a prior history of ipsilateral invasive breast cancer or carcinoma in situ who present with a new primary.\n12. Patients with known active, infectious Hepatitis B, Hepatitis C, or HIV.'}, 'identificationModule': {'nctId': 'NCT00999804', 'acronym': 'HELEX', 'briefTitle': 'Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Breast Care Center'}, 'officialTitle': 'TBCRC 023: A Randomized Multicenter Phase II Neoadjuvant Trial of Lapatinib Pus Trastuzumab, With or Without Endocrine Therapy for 12 Weeks vs. 24 Weeks in Patients With HER2 Overexpressing Breast Cancer', 'orgStudyIdInfo': {'id': 'H-25846'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '24-week arm', 'description': 'Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.', 'interventionNames': ['Drug: Lapatinib', 'Drug: Letrozole', 'Drug: Trastuzumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '12-week arm', 'description': 'Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.', 'interventionNames': ['Drug: Lapatinib', 'Drug: Letrozole', 'Drug: Trastuzumab']}], 'interventions': [{'name': 'Lapatinib', 'type': 'DRUG', 'otherNames': ['TyKerb'], 'description': '1000 mg of Lapatinib by mouth daily', 'armGroupLabels': ['12-week arm', '24-week arm']}, {'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'Letrozole, 2.5 mg by mouth daily (for hormone receptor positive participants only)', 'armGroupLabels': ['12-week arm', '24-week arm']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': '6 mg/kg intravenously, every 3 weeks', 'armGroupLabels': ['12-week arm', '24-week arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine Lester and Sue Smith Breast Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Mothaffar Rimawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Breast Care Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Translational Breast Cancer Research Consortium', 'class': 'OTHER'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mothaffar Rimawi', 'investigatorAffiliation': 'Baylor Breast Care Center'}}}}