Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-13 @ 11:21 AM
Study NCT ID:
NCT03901469
Status:
TERMINATED
Last Update Posted:
2025-10-07
First Post:
2019-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'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': 'C586365', 'term': 'talazoparib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ZEN003694-004@zenithepigenetics.com', 'phone': '587-390-7865', 'title': 'Zenith Study Team', 'organization': 'Zenith Epigenetics'}, 'certainAgreement': {'otherDetails': 'Disclosure permission may only be granted upon sponsor review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months.', 'description': "Adverse events were collected in all participants. For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose.", 'eventGroups': [{'id': 'EG000', 'title': 'Part 1 Dose Escalation: Cohort 1', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part 2 Stages 1 & 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 42, 'seriousNumAtRisk': 42, 'deathsNumAffected': 3, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'deathsNumAffected': 5, 'seriousNumAffected': 10}, {'id': 'EG005', 'title': 'Expansion Cohort B - ZEN003694 Monotherapy', 'description': 'ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Expansion Cohort B - ZEN003694 Combination', 'description': 'Post cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 32, 'seriousNumAtRisk': 32, 'deathsNumAffected': 1, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dyschromatopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, 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'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abnormal uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1 and Part 2: Number of Participants With Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Dose Escalation: Cohort 1', 'description': 'ZEN003694 48 mg PO QD with 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Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG003', 'title': 'Part 2 Stages 1 & 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. 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Includes sites in the US and EU.'}], 'classes': [{'title': 'Patients Reporting at least one TEAE related to study treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Patients reporting at least one Serious TEAE related to study treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Dose-limiting Toxicities (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Dose Escalation: Cohort 1', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}], 'classes': [{'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count decreased/ Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1, Up to 1 month', 'description': 'Determination of DLT will be made during the first 28 days of treatment (i.e., Cycle 1) in the dose escalation phase. A DLT is defined as a clinically significant AE or laboratory abnormality that is considered possibly, probably or definitely related to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Part 2: Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Stages 1 & 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. 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Patients who were determined to be "unevaluable" during Cycle 1 by the Sponsor and Investigator will not be included in the Efficacy Population.'}, {'type': 'PRIMARY', 'title': 'Expansion Cohort A: Objective Response Rate (ORR) by RECIST v1.1 (CR or PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. 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Includes sites in the US and EU.'}, {'id': 'OG004', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From screening up to 18 months', 'description': 'Percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD ≥ 4 cycles) by RECIST 1.1', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have received at least 3 weeks of per-protocol treatment during Cycle 1, or \\<3 weeks of treatment in Cycle 1 because of a DLT, will comprise the Efficacy Population. 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Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.'}], 'classes': [{'title': 'Patients reporting at least one TEAE related to study treatment', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Patients reporting at least one Serious TEAE related to study treatment', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to 18 months', 'description': 'Incidence of Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE) in Part 2, Expansion Cohorts A and C', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part 1, Part 2, Expansion Cohorts A & C: Evaluate Median Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Dose Escalation - Cohort 1', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG003', 'title': 'Part 2 Stages 1 & 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG004', 'title': 'Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG005', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.42', 'comment': 'Insufficient sample size for software to calculate the lower confidence interval limit for median PFS', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '9.2'}, {'value': '5.06', 'comment': 'Insufficient sample size for software to calculate the lower and upper confidence interval limit for median PFS', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.51', 'comment': 'Insufficient sample size for software to calculate the lower confidence interval limit for median PFS', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '14.62'}, {'value': '3.25', 'groupId': 'OG003', 'lowerLimit': '1.84', 'upperLimit': '5.09'}, {'value': '1.38', 'groupId': 'OG004', 'lowerLimit': '1.15', 'upperLimit': '2.73'}, {'value': '1.71', 'groupId': 'OG005', 'lowerLimit': '1.41', 'upperLimit': '3.88'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From screening up to 18 months', 'description': 'Median progression-free survival is the time from randomization to documented disease progression or death', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have received at least 3 weeks of per-protocol treatment during Cycle 1, or \\<3 weeks of treatment in Cycle 1 because of a DLT, will comprise the Efficacy Population. Patients who were determined to be "unevaluable" during Cycle 1 by the Sponsor and Investigator will not be included in the Efficacy Population.'}, {'type': 'SECONDARY', 'title': 'Part 2, Expansion Cohorts A and C: Evaluate Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Stages 1 & 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '16.6'}, {'value': '8.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From screening up to 18 months', 'description': 'For subjects with a confirmed response of PR or CR, duration of response is measured from the date of the first response until the time that overall disease progression (radiographic progressive disease or clinical deterioration) or death is documented.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a confirmed response of PR or CR are included for the duration of response analysis'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Measure the Pharmacokinetic Parameter (PK) of Cmax of ZEN003694 and ZEN003791 (Active Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Dose Escalation: Cohort 1', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG003', 'title': 'Part 2 - Stages 1 and 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}], 'classes': [{'title': 'Cycle 1 Day 1 - ZEN003694', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '406', 'spread': '166', 'groupId': 'OG000'}, {'value': '407', 'spread': '104', 'groupId': 'OG001'}, {'value': '143', 'spread': '119', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Day 1 - ZEN003694', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '217', 'spread': '154', 'groupId': 'OG000'}, {'value': '465', 'spread': '158', 'groupId': 'OG001'}, {'value': '401', 'spread': '174', 'groupId': 'OG002'}, {'value': '513', 'spread': '196', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 1 - ZEN003791', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '202', 'spread': '60', 'groupId': 'OG000'}, {'value': '187', 'spread': '65', 'groupId': 'OG001'}, {'value': '66', 'spread': '30', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Day 1 - ZEN003791', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88', 'spread': '30', 'groupId': 'OG000'}, {'value': '242', 'spread': '81', 'groupId': 'OG001'}, {'value': '218', 'spread': '80', 'groupId': 'OG002'}, {'value': '285', 'spread': '127', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Cycle 1 Day 1: Pre-dose, 15 min, 30 min, 1 hour, 2 hour, 4 hour, 6 hour, and 8 hours post-dose. Parts 1 & 2: Cycle 2 Day 1: Pre-dose, 1 hour, 2 hour, and 4 hours post-dose. (cycles are 28 days)', 'description': 'Cmax is defined as the maximum or peak plasma concentration of drug (calculated from samples taken over a 4-hour or 8-hour time period). Cmax(0-8h) was calculated for Cycle 1, Day 1. Cmax(0-4h) was calculated for Cycle 2, Day 1. Pre-dose is time 0 for calculations.', 'unitOfMeasure': 'ng/ML', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 (All evaluable participants): C1D1; Parts 1 \\& 2 (All evaluable participants): C2D1'}, {'type': 'SECONDARY', 'title': 'Part 1 and Part 2: Measure the Pharmacokinetic (PK) Parameter of Combined AUC(0-4h or 0-8h) of ZEN003694 and ZEN003791 (Active Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Dose Escalation: Cohort 1', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG003', 'title': 'Part 2 - Stages 1 and 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}], 'classes': [{'title': 'AUC(0-8h) Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2680', 'spread': '894', 'groupId': 'OG000'}, {'value': '2502', 'spread': '994', 'groupId': 'OG001'}, {'value': '1013', 'spread': '733', 'groupId': 'OG002'}]}]}, {'title': 'AUC(0-4h) Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3067', 'spread': '1628', 'groupId': 'OG000'}, {'value': '5615', 'spread': '696', 'groupId': 'OG001'}, {'value': '7375', 'spread': '3818', 'groupId': 'OG002'}, {'value': '1994', 'spread': '797', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Cycle 1 Day 1: Pre-dose, 15 min, 30 min, 1 hour, 2 hour, 4 hour, 6 hour, and 8 hours post-dose. Parts 1 & 2: Cycle 2 Day 1: Pre-dose, 1 hour, 2 hour, and 4 hours post-dose. (cycles are 28 days)', 'description': 'AUC(0-4h or 0-8h) is defined as the area under the curve (plasma concentration of drug calculated from samples taken over a 4-hour or 8-hour time period). AUC(0-8h) was calculated for Cycle 1, Day 1. AUC(0-4h) was calculated for Cycle 2, Day 1. Pre-dose is time 0 for calculations.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 (All evaluable participants): C1D1; Parts 1 \\& 2 (All evaluable participants): C2D1'}, {'type': 'SECONDARY', 'title': 'Part 1 & 2: Measure Plasma Concentrations of Talazoparib.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Dose Escalation: Cohort 1', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG003', 'title': 'Part 2 - Stages 1 and 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}], 'classes': [{'title': 'Cycle 1 Day 15 Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4813.3', 'spread': '2278.1', 'groupId': 'OG000'}, {'value': '4582', 'spread': '1562.5', 'groupId': 'OG001'}, {'value': '5650', 'spread': '2714.1', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Day 1 Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3814', 'spread': '3092', 'groupId': 'OG000'}, {'value': '3584.3', 'spread': '2819.4', 'groupId': 'OG001'}, {'value': '8220', 'spread': '4073.1', 'groupId': 'OG002'}, {'value': '3129.8', 'spread': '2190.2', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 2 Day 15 Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3952.5', 'spread': '1348.7', 'groupId': 'OG000'}, {'value': '4892.5', 'spread': '1957.5', 'groupId': 'OG001'}, {'value': '4840', 'spread': '3097.1', 'groupId': 'OG002'}, {'value': '4240', 'spread': '2110.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Cycle 1 Day 15: Pre-dose; Parts 1& 2 Cycle 2 Day 1: Pre-dose; Cycle 2 Day 15: Pre-dose (each cycle is 28 days)', 'description': 'Plasma concentrations of talazoparib will be measured.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 (All evaluable participants): C1D15; Parts 1 \\& 2 (All evaluable participants): C2D1 \\& C2D15'}, {'type': 'SECONDARY', 'title': 'Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Expansion Cohort B - ZEN003694 Monotherapy', 'description': 'ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG002', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.'}], 'classes': [{'title': 'ZEN003694 Cycle 2 Day 1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.82', 'spread': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003694 Cycle 2 Day 1 - 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '383.9', 'spread': '259.1', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003694 Cycle 2 Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '397.2', 'spread': '232.4', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003694 Cycle 2 Day 1 - 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '345.3', 'spread': '116.9', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003694 Cycle 2 Day 15 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.2', 'spread': '28.6', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003791 Cycle 2 Day 1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '110.2', 'spread': '84.3', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003791 Cycle 2 Day 1 - 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '231.0', 'spread': '158.9', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003791 Cycle 2 Day 1 - 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '268.4', 'spread': '207.0', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003791 Cycle 2 Day 1 - 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '303.8', 'spread': '154.1', 'groupId': 'OG002'}]}]}, {'title': 'ZEN003791 Cycle 2 Day 15 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '169.0', 'spread': '111.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 Day 1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose; Cycle 2 Day 15: Pre-dose (each cycle is 28 days)', 'description': 'Plasma concentrations of ZEN003694 and the active metabolite ZEN003791 will be measured.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts A and B - Study was terminated prior to PK analysis for samples collected from cohorts A and B, therefore data was not obtained. Data will never be obtained and reported for this measure. Cohort C - All Evaluable Participants.'}, {'type': 'SECONDARY', 'title': 'Expansion Cohorts A and C: Measure Plasma Concentrations of Talazoparib.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'OG001', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.'}], 'classes': [{'title': 'Talazoparib Cycle 2 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2152.8', 'spread': '2031.9', 'groupId': 'OG001'}]}]}, {'title': 'Talazoparib Cycle 2 Day 15 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4494.1', 'spread': '3139.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 Day 1: Pre-dose, Cycle 2 Day 15: Pre-dose (each cycle is 28 days)', 'description': 'Plasma concentrations of talazoparib will be measured.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohorts A and B - Study was terminated prior to PK analysis for samples collected from cohorts A and B, therefore data was not obtained. Data will never be obtained and reported for this measure. Cohort C - All Evaluable Participants.'}, {'type': 'SECONDARY', 'title': 'Part 2, Expansion Cohorts A and C: Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by EORTC QLQ-C30 for Overall Duration', 'timeFrame': 'Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)', 'description': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Part 2, Expansion Cohorts A and C: Change From Baseline in Breast Symptoms Scale as Assessed by the EORTC-QLQ-BR23', 'timeFrame': 'Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)', 'description': 'European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23) is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 Dose Escalation: Cohort 1', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'FG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'FG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'FG003', 'title': 'Part 2 Stages 1 & 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'FG004', 'title': 'Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'FG005', 'title': 'Expansion Cohort B - ZEN003694 Monotherapy', 'description': 'ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'FG006', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Radiographic Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '11'}]}, {'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Termination of study by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Not Reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at nineteen investigational sites in the United States (eight), Belgium (two), Spain (two), and China (seven) between June 2019 and March 2024', 'preAssignmentDetails': '115 participants were enrolled and treated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 Dose Escalation: Cohort 1', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'BG001', 'title': 'Part 1 Dose Escalation: Cohort 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'BG002', 'title': 'Part 1 Dose Escalation: Cohort 3', 'description': 'ZEN003694 36 mg PO QD with Talazoparib 1 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'BG003', 'title': 'Part 2 Stages 1 & 2', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'BG004', 'title': 'Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib 0.75 mg PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'BG005', 'title': 'Expansion Cohort B - ZEN003694 Monotherapy', 'description': 'ZEN003694 48 mg PO QD as monotherapy at the in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 48 mg PO QD with 0.75 mg Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.'}, {'id': 'BG006', 'title': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients', 'description': 'ZEN003694 48 mg PO QD with Talazoparib PO QD (RP2D) in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '57.2', 'spread': '14.77', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '11.72', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '4.04', 'groupId': 'BG002'}, {'value': '52.2', 'spread': '12.09', 'groupId': 'BG003'}, {'value': '49.2', 'spread': '11.74', 'groupId': 'BG004'}, {'value': '55.3', 'spread': '10.12', 'groupId': 'BG005'}, {'value': '54.9', 'spread': '10.70', 'groupId': 'BG006'}, {'value': '53.0', 'spread': '11.57', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '74'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '69'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '57', 'upperLimit': '64'}, {'value': '51.5', 'groupId': 'BG003', 'lowerLimit': '28', 'upperLimit': '80'}, {'value': '49', 'groupId': 'BG004', 'lowerLimit': '32', 'upperLimit': '68'}, {'value': '50', 'groupId': 'BG005', 'lowerLimit': '49', 'upperLimit': '67'}, {'value': '55', 'groupId': 'BG006', 'lowerLimit': '34', 'upperLimit': '77'}, {'value': '52', 'groupId': 'BG007', 'lowerLimit': '28', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '95', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '34', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '68', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '110', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '164.60', 'spread': '5.088', 'groupId': 'BG000'}, {'value': '163.74', 'spread': '5.882', 'groupId': 'BG001'}, {'value': '165.00', 'spread': '3.606', 'groupId': 'BG002'}, {'value': '162.42', 'spread': '6.730', 'groupId': 'BG003'}, {'value': '163.66', 'spread': '5.872', 'groupId': 'BG004'}, {'value': '165.67', 'spread': '16.512', 'groupId': 'BG005'}, {'value': '157.2', 'spread': '4.84', 'groupId': 'BG006'}, {'value': '161.48', 'spread': '6.07', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not available for all study participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '110', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '164.15', 'groupId': 'BG000', 'lowerLimit': '158.0', 'upperLimit': '170.0'}, {'value': '166.35', 'groupId': 'BG001', 'lowerLimit': '150.0', 'upperLimit': '167.6'}, {'value': '164.0', 'groupId': 'BG002', 'lowerLimit': '162.0', 'upperLimit': '169.0'}, {'value': '164.5', 'groupId': 'BG003', 'lowerLimit': '148.5', 'upperLimit': '174.0'}, {'value': '165.2', 'groupId': 'BG004', 'lowerLimit': '150.2', 'upperLimit': '170.2'}, {'value': '175.2', 'groupId': 'BG005', 'lowerLimit': '146.6', 'upperLimit': '175.2'}, {'value': '157.5', 'groupId': 'BG006', 'lowerLimit': '146', 'upperLimit': '166'}, {'value': '162.5', 'groupId': 'BG007', 'lowerLimit': '146', 'upperLimit': '175.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data not available for all study participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '76.32', 'spread': '21.731', 'groupId': 'BG000'}, {'value': '79.35', 'spread': '23.396', 'groupId': 'BG001'}, {'value': '74.00', 'spread': '18.672', 'groupId': 'BG002'}, {'value': '67.25', 'spread': '12.804', 'groupId': 'BG003'}, {'value': '72.98', 'spread': '14.325', 'groupId': 'BG004'}, {'value': '62.30', 'spread': '5.726', 'groupId': 'BG005'}, {'value': '61.55', 'spread': '10.212', 'groupId': 'BG006'}, {'value': '68.07', 'spread': '13.531', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'BG000', 'lowerLimit': '55.7', 'upperLimit': '116.0'}, {'value': '72.9', 'groupId': 'BG001', 'lowerLimit': '59.0', 'upperLimit': '124.7'}, {'value': '66.8', 'groupId': 'BG002', 'lowerLimit': '60.0', 'upperLimit': '95.2'}, {'value': '66.0', 'groupId': 'BG003', 'lowerLimit': '44.9', 'upperLimit': '99.5'}, {'value': '77.7', 'groupId': 'BG004', 'lowerLimit': '47.3', 'upperLimit': '93.0'}, {'value': '64.5', 'groupId': 'BG005', 'lowerLimit': '55.8', 'upperLimit': '66.6'}, {'value': '59.0', 'groupId': 'BG006', 'lowerLimit': '41.5', 'upperLimit': '80.0'}, {'value': '65.4', 'groupId': 'BG007', 'lowerLimit': '41.5', 'upperLimit': '124.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '110', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '28.50', 'spread': '9.682', 'groupId': 'BG000'}, {'value': '29.47', 'spread': '7.961', 'groupId': 'BG001'}, {'value': '27.01', 'spread': '5.563', 'groupId': 'BG002'}, {'value': '25.84', 'spread': '4.710', 'groupId': 'BG003'}, {'value': '27.01', 'spread': '4.917', 'groupId': 'BG004'}, {'value': '22.89', 'spread': '2.683', 'groupId': 'BG005'}, {'value': '24.928', 'spread': '4.057', 'groupId': 'BG006'}, {'value': '26.13', 'spread': '5.029', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not available for all study participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '110', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '24.61', 'groupId': 'BG000', 'lowerLimit': '21.4', 'upperLimit': '46.5'}, {'value': '27.65', 'groupId': 'BG001', 'lowerLimit': '21.1', 'upperLimit': '45.4'}, {'value': '24.84', 'groupId': 'BG002', 'lowerLimit': '22.9', 'upperLimit': '33.3'}, {'value': '25.90', 'groupId': 'BG003', 'lowerLimit': '19.1', 'upperLimit': '40.1'}, {'value': '27.16', 'groupId': 'BG004', 'lowerLimit': '19.0', 'upperLimit': '34.6'}, {'value': '21.70', 'groupId': 'BG005', 'lowerLimit': '21.0', 'upperLimit': '26.0'}, {'value': '25.195', 'groupId': 'BG006', 'lowerLimit': '17.73', 'upperLimit': '33.30'}, {'value': '25.57', 'groupId': 'BG007', 'lowerLimit': '17.73', 'upperLimit': '46.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data not available for all study participants'}, {'title': 'ECOG Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '115', 'groupId': 'BG007'}]}], 'categories': [{'title': 'ECOG 0', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '66', 'groupId': 'BG007'}]}, {'title': 'ECOG 1', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}]}, {'title': 'ECOG 2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG Performance Status\n\n0 - Fully active, able to carry on all pre-disease performance without restriction\n\n1. \\- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work)\n2. \\- Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours\n3. \\- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours\n4. \\- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair\n5. \\- Dead', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated safety population consisted of all treated participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-26', 'size': 2644253, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-11T11:53', 'hasProtocol': True}, {'date': '2023-09-01', 'size': 1020405, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-11T11:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'whyStopped': 'Parts 1 and 2 and Expansion Cohort C were completed. Expansion Cohorts A and B were discontinued based on results from an interim futility analysis and not due to safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2019-03-22', 'resultsFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-17', 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 and Part 2: Number of Participants With Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE)', 'timeFrame': 'Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months'}, {'measure': 'Part 1: Number of Participants With Dose-limiting Toxicities (DLT)', 'timeFrame': 'Cycle 1, Up to 1 month', 'description': 'Determination of DLT will be made during the first 28 days of treatment (i.e., Cycle 1) in the dose escalation phase. A DLT is defined as a clinically significant AE or laboratory abnormality that is considered possibly, probably or definitely related to study drug.'}, {'measure': 'Part 2: Clinical Benefit Rate (CBR)', 'timeFrame': 'From screening up to 18 months', 'description': 'Percentage of patients with a best overall response of confirmed complete response (CR), partial response (PR), or stable disease (SD ≥ 4 cycles) by RECIST v1.1'}, {'measure': 'Expansion Cohort A: Objective Response Rate (ORR) by RECIST v1.1 (CR or PR)', 'timeFrame': 'From screening up to 18 months', 'description': 'Percentage of participants with a confirmed complete response (CR) or partial response (PR) by RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'Part 1, Expansion Cohorts A and C: Clinical Benefit Rate (CBR)', 'timeFrame': 'From screening up to 18 months', 'description': 'Percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD ≥ 4 cycles) by RECIST 1.1'}, {'measure': 'Part 1, Part 2, and Expansion Cohort C: Objective Response Rate (ORR)', 'timeFrame': 'From screening up to 18 months', 'description': 'Percentage of participants with a confirmed complete response (CR) or partial response (PR) by RECIST 1.1'}, {'measure': 'Part 2, Expansion Cohorts A and C: Safety Profile of ZEN003694 in Combination With Talazoparib.', 'timeFrame': 'From screening up to 18 months', 'description': 'Incidence of Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE) in Part 2, Expansion Cohorts A and C'}, {'measure': 'Part 1, Part 2, Expansion Cohorts A & C: Evaluate Median Progression-free Survival', 'timeFrame': 'From screening up to 18 months', 'description': 'Median progression-free survival is the time from randomization to documented disease progression or death'}, {'measure': 'Part 2, Expansion Cohorts A and C: Evaluate Duration of Response (DOR)', 'timeFrame': 'From screening up to 18 months', 'description': 'For subjects with a confirmed response of PR or CR, duration of response is measured from the date of the first response until the time that overall disease progression (radiographic progressive disease or clinical deterioration) or death is documented.'}, {'measure': 'Part 1 and Part 2: Measure the Pharmacokinetic Parameter (PK) of Cmax of ZEN003694 and ZEN003791 (Active Metabolite)', 'timeFrame': 'Part 1: Cycle 1 Day 1: Pre-dose, 15 min, 30 min, 1 hour, 2 hour, 4 hour, 6 hour, and 8 hours post-dose. Parts 1 & 2: Cycle 2 Day 1: Pre-dose, 1 hour, 2 hour, and 4 hours post-dose. (cycles are 28 days)', 'description': 'Cmax is defined as the maximum or peak plasma concentration of drug (calculated from samples taken over a 4-hour or 8-hour time period). Cmax(0-8h) was calculated for Cycle 1, Day 1. Cmax(0-4h) was calculated for Cycle 2, Day 1. Pre-dose is time 0 for calculations.'}, {'measure': 'Part 1 and Part 2: Measure the Pharmacokinetic (PK) Parameter of Combined AUC(0-4h or 0-8h) of ZEN003694 and ZEN003791 (Active Metabolite)', 'timeFrame': 'Part 1: Cycle 1 Day 1: Pre-dose, 15 min, 30 min, 1 hour, 2 hour, 4 hour, 6 hour, and 8 hours post-dose. Parts 1 & 2: Cycle 2 Day 1: Pre-dose, 1 hour, 2 hour, and 4 hours post-dose. (cycles are 28 days)', 'description': 'AUC(0-4h or 0-8h) is defined as the area under the curve (plasma concentration of drug calculated from samples taken over a 4-hour or 8-hour time period). AUC(0-8h) was calculated for Cycle 1, Day 1. AUC(0-4h) was calculated for Cycle 2, Day 1. Pre-dose is time 0 for calculations.'}, {'measure': 'Part 1 & 2: Measure Plasma Concentrations of Talazoparib.', 'timeFrame': 'Part 1: Cycle 1 Day 15: Pre-dose; Parts 1& 2 Cycle 2 Day 1: Pre-dose; Cycle 2 Day 15: Pre-dose (each cycle is 28 days)', 'description': 'Plasma concentrations of talazoparib will be measured.'}, {'measure': 'Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.', 'timeFrame': 'Cycle 2 Day 1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose; Cycle 2 Day 15: Pre-dose (each cycle is 28 days)', 'description': 'Plasma concentrations of ZEN003694 and the active metabolite ZEN003791 will be measured.'}, {'measure': 'Expansion Cohorts A and C: Measure Plasma Concentrations of Talazoparib.', 'timeFrame': 'Cycle 2 Day 1: Pre-dose, Cycle 2 Day 15: Pre-dose (each cycle is 28 days)', 'description': 'Plasma concentrations of talazoparib will be measured.'}, {'measure': 'Part 2, Expansion Cohorts A and C: Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by EORTC QLQ-C30 for Overall Duration', 'timeFrame': 'Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)', 'description': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.'}, {'measure': 'Part 2, Expansion Cohorts A and C: Change From Baseline in Breast Symptoms Scale as Assessed by the EORTC-QLQ-BR23', 'timeFrame': 'Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)', 'description': 'European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23) is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TNBC', 'ZEN003694', 'ZEN-3694', 'Talazoparib', 'Breast Cancer', 'PARPi', 'poly ADP ribose polymerase', 'bromodomain', 'BETi'], 'conditions': ['Triple Negative Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34385584', 'type': 'DERIVED', 'citation': 'Kharenko OA, Patel RG, Calosing C, van der Horst EH. Combination of ZEN-3694 with CDK4/6 inhibitors reverses acquired resistance to CDK4/6 inhibitors in ER-positive breast cancer. Cancer Gene Ther. 2022 Jun;29(6):859-869. doi: 10.1038/s41417-021-00375-9. Epub 2021 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'This is a two-part open label, non-randomized, Phase 2, study of ZEN003694 in combination with Talazoparib in patients with TNBC without germline mutations of BRCA1 or BRCA2. Part 1 is a dose escalation and Part 2 is a Simon 2-Stage design. There are 3 expansion cohorts: Expansion Cohort A (combination treatment in post-TROP2-ADC patients), Expansion Cohort B (ZEN003694 monotherapy), and Expansion Cohort C (combination treatment in TROP2-ADC-naive patients).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Females or males age ≥ 18 years (at time of signing informed consent)\n2. Parts 1 and 2 only: Histologically confirmed metastatic or recurrent or locally advanced triple-negative breast cancer (estrogen receptor (ER) ≤10%; progesterone receptor (PR) ≤10%; and HER2 negative by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH)\n\n Expansion only: Histologically confirmed metastatic or recurrent, or locally advanced triple-negative breast cancer as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.\n3. Patient is not a candidate for endocrine based therapy, based on Investigator judgement\n4. Have a history of progressive disease despite prior therapy\n5. Part 1: Have had at least 1 prior cytotoxic chemotherapy.\n\n Part 2: Have had no more than 2 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease, unless approved by the Sponsor (no limit on prior targeted anticancer therapies such as mechanistic target or rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF.)\n\n Expansion Cohort A (combination treatment in post-TROP2-ADC patients): Have received TROP2-ADC therapy for unresectable locally advanced or metastatic disease.\n\n Expansion Cohort B (ZEN003694 monotherapy): Have had at least 1 prior systemic therapy for locally advanced or metastatic disease which may or may not have included a TROP2-ADC.\n\n Expansion Cohort C (combination treatment in TROP2-ADC-naive patients): Have had at least 1 prior systemic therapy for locally advanced or metastatic disease and who have not received prior TROP2-ADC therapy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Part 2 and Expansion only: Measurable disease per RECIST version 1.1\n\nExclusion Criteria:\n\n1. Documented germline mutations of BRCA1 or BRCA2\n2. Parts 1 and 2 only: Evidence of disease progression during platinum treatment either in the neoadjuvant or in the metastatic setting. For patients receiving platinum in the neoadjuvant setting, at least 6 months must have elapsed between the last dose of platinum-based treatment and enrollment\n3. Part 2 only: Patients with inflammatory breast cancer\n4. Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug.\n5. Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.\n6. Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed\n7. Prior anticancer therapy (chemotherapy, radiation, hormone therapy, immunotherapy or investigational agent) within 3 weeks from the start of study drug (except for nitrosoureas and mitomycin C within 6 weeks from start of study drug)\n8. Parts 1 and 2 only: Radiation to \\>25% of the bone marrow\n9. Treatment with a bone-targeted radionuclide within 6 weeks of first dose of study drug\n10. Have previously received an investigational BET inhibitor (including previous participation in studies with the Sponsor's drug, ZEN003694); except for patients in Expansion Cohort B who received ZEN003694 monotherapy and are eligible to cross-over to combination treatment\n11. Prior treatment with a PARP inhibitor\n12. QTcF interval \\> 470 msec\n13. Insufficient recovery (i.e., has not recovered to at least Grade 1) from prior treatment-related toxicities except for alopecia, fatigue and Grade 2 neuropathy\n14. Non-healing wound, ulcer or bone fracture (not including a pathological bone fracture caused by a pre-existing pathological bone lesion)\n15. Parts 1 and 2 only: Brain metastases not adequately treated and clinically stable (at the discretion of the Investigator) for at least 3 months prior to the start of study treatment, unless a shorter interval is approved by the Sponsor's Medical Monitor\n\n Expansion only: Progressive, symptomatic, or untreated brain metastases. CNS metastases treated definitively with surgery and/or radiation must be radiographically stable based on imaging at least 3 months after definitive treatment. CNS metastases requiring steroid doses equivalent to prednisone doses \\>10 mg daily or an increase in steroid doses due to CNS disease prior to consent are not eligible\n16. Expansion only: Disease initially diagnosed with expression of estrogen receptor (ER) or progesterone receptor (PR) as ≥5%\n17. Expansion only: Patients treated with prior endocrine therapy"}, 'identificationModule': {'nctId': 'NCT03901469', 'acronym': 'TNBC', 'briefTitle': 'A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zenith Epigenetics'}, 'officialTitle': 'A Phase 2b Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'ZEN003694-004'}, 'secondaryIdInfos': [{'id': '2018-003906-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 and Part 2', 'description': 'ZEN003694 will be administered PO QD with Talazoparib PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'interventionNames': ['Drug: ZEN003694', 'Drug: Talazoparib']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Cohort A - Combination Treatment in post-TROP2-ADC patients', 'description': 'ZEN003694 will be administered PO QD with Talazoparib PO QD at the RP2D in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'interventionNames': ['Drug: ZEN003694', 'Drug: Talazoparib']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Cohort B - ZEN003694 Monotherapy', 'description': 'ZEN003694 will be administered PO QD as monotherapy at the RP2D in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 PO QD with Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.', 'interventionNames': ['Drug: ZEN003694']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patients', 'description': 'ZEN003694 will be administered PO QD with Talazoparib PO QD at the RP2D in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.', 'interventionNames': ['Drug: ZEN003694', 'Drug: Talazoparib']}], 'interventions': [{'name': 'ZEN003694', 'type': 'DRUG', 'otherNames': ['ZEN-3694'], 'description': 'PO QD', 'armGroupLabels': ['Expansion Cohort A - Combination Treatment in post-TROP2-ADC patients', 'Expansion Cohort B - ZEN003694 Monotherapy', 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patients', 'Part 1 and Part 2']}, {'name': 'Talazoparib', 'type': 'DRUG', 'otherNames': ['Talzenna'], 'description': 'PO QD', 'armGroupLabels': ['Expansion Cohort A - Combination Treatment in post-TROP2-ADC patients', 'Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patients', 'Part 1 and Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66203', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'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': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology (Sarah Cannon)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '1070', 'city': 'Anderlecht', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '233000', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hosptial of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510289', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '272000', 'city': 'Jining', 'state': 'Shandong', 'country': 'China', 'facility': 'Affliated Hospital of Jining Medical University', 'geoPoint': {'lat': 35.405, 'lon': 116.58139}}, {'zip': '641100', 'city': 'Neijiang', 'state': 'Sichuan', 'country': 'China', 'facility': "The Second People's Hospital of Neijiang", 'geoPoint': {'lat': 29.58354, 'lon': 105.06216}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjing Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron Institute of Oncology (VHIO)", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'START Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zenith Epigenetics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Newsoara Biopharma Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}