A Study of ZEN003694 and Talazoparib in Patients With Tri... | NCT03901469 | Trialant
NCT03901469
Sponsor
Zenith Epigenetics
Status
Terminated
Last Update Posted
Oct 7, 2025Actual
Enrollment
115Actual
Phase
Phase 2
Conditions
Triple Negative Breast Cancer
Interventions
ZEN003694
Talazoparib
Countries
United States
Belgium
China
Spain
Protocol Section
Identification Module
NCT ID
NCT03901469
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ZEN003694-004
Secondary IDs
ID
Type
Description
Link
2018-003906-26
EudraCT Number
Brief Title
A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer
Official Title
A Phase 2b Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer
Acronym
TNBC
Organization
Zenith EpigeneticsINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
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.
Expanded Access Info
No
Start Date
Jun 26, 2019Actual
Primary Completion Date
Mar 7, 2024Actual
Completion Date
Mar 7, 2024Actual
First Submitted Date
Mar 22, 2019
First Submission Date that Met QC Criteria
Apr 1, 2019
First Posted Date
Apr 3, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Mar 14, 2025
Results First Submitted that Met QC Criteria
Sep 17, 2025
Results First Posted Date
Oct 7, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 17, 2025
Last Update Posted Date
Oct 7, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Zenith EpigeneticsINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Newsoara Biopharma Co., Ltd.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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).
Detailed Description
Not provided
Conditions Module
Conditions
Triple Negative Breast Cancer
Keywords
TNBC
ZEN003694
ZEN-3694
Talazoparib
Breast Cancer
PARPi
poly ADP ribose polymerase
bromodomain
BETi
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
115Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 and Part 2
Experimental
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.
Drug: ZEN003694
Drug: Talazoparib
Expansion Cohort A - Combination Treatment in post-TROP2-ADC patients
Experimental
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.
Drug: ZEN003694
Drug: Talazoparib
Expansion Cohort B - ZEN003694 Monotherapy
Experimental
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.
Drug: ZEN003694
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patients
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ZEN003694
Drug
PO QD
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
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1 and Part 2: Number of Participants With Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE)
Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months
Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
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.
Cycle 1, Up to 1 month
Part 2: Clinical Benefit Rate (CBR)
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
From screening up to 18 months
Expansion Cohort A: Objective Response Rate (ORR) by RECIST v1.1 (CR or PR)
Percentage of participants with a confirmed complete response (CR) or partial response (PR) by RECIST 1.1
From screening up to 18 months
Secondary Outcomes
Measure
Description
Time Frame
Part 1, Expansion Cohorts A and C: Clinical Benefit Rate (CBR)
Percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD ≥ 4 cycles) by RECIST 1.1
From screening up to 18 months
Part 1, Part 2, and Expansion Cohort C: Objective Response Rate (ORR)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Females or males age ≥ 18 years (at time of signing informed consent)
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)
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.
Patient is not a candidate for endocrine based therapy, based on Investigator judgement
Have a history of progressive disease despite prior therapy
Part 1: Have had at least 1 prior cytotoxic chemotherapy.
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.)
Expansion Cohort A (combination treatment in post-TROP2-ADC patients): Have received TROP2-ADC therapy for unresectable locally advanced or metastatic disease.
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.
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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Part 2 and Expansion only: Measurable disease per RECIST version 1.1
Exclusion Criteria:
Documented germline mutations of BRCA1 or BRCA2
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
Part 2 only: Patients with inflammatory breast cancer
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.
Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.
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
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)
Parts 1 and 2 only: Radiation to >25% of the bone marrow
Treatment with a bone-targeted radionuclide within 6 weeks of first dose of study drug
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
Prior treatment with a PARP inhibitor
QTcF interval > 470 msec
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
Non-healing wound, ulcer or bone fracture (not including a pathological bone fracture caused by a pre-existing pathological bone lesion)
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
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
Expansion only: Disease initially diagnosed with expression of estrogen receptor (ER) or progesterone receptor (PR) as ≥5%
Expansion only: Patients treated with prior endocrine therapy
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
115 participants were enrolled and treated in the study.
Recruitment Details
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
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 Dose Escalation: Cohort 1
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.
FG001
Part 1 Dose Escalation: Cohort 2
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 26, 2022
Apr 11, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
None (Open Label)
Who Masked
Not provided
Drug: ZEN003694
Drug: Talazoparib
Part 1 and Part 2
ZEN-3694
Talazoparib
Drug
PO QD
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
Talzenna
Percentage of participants with a confirmed complete response (CR) or partial response (PR) by RECIST 1.1
From screening up to 18 months
Part 2, Expansion Cohorts A and C: Safety Profile of ZEN003694 in Combination With Talazoparib.
Incidence of Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE) in Part 2, Expansion Cohorts A and C
From screening up to 18 months
Part 1, Part 2, Expansion Cohorts A & C: Evaluate Median Progression-free Survival
Median progression-free survival is the time from randomization to documented disease progression or death
From screening up to 18 months
Part 2, Expansion Cohorts A and C: Evaluate Duration of Response (DOR)
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.
From screening up to 18 months
Part 1 and Part 2: Measure the Pharmacokinetic Parameter (PK) of Cmax of ZEN003694 and ZEN003791 (Active Metabolite)
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.
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)
Part 1 and Part 2: Measure the Pharmacokinetic (PK) Parameter of Combined AUC(0-4h or 0-8h) of ZEN003694 and ZEN003791 (Active Metabolite)
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.
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)
Part 1 & 2: Measure Plasma Concentrations of Talazoparib.
Plasma concentrations of talazoparib will be measured.
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)
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
Plasma concentrations of ZEN003694 and the active metabolite ZEN003791 will be measured.
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)
Expansion Cohorts A and C: Measure Plasma Concentrations of Talazoparib.
Plasma concentrations of talazoparib will be measured.
Cycle 2 Day 1: Pre-dose, Cycle 2 Day 15: Pre-dose (each cycle is 28 days)
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
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.
Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)
Part 2, Expansion Cohorts A and C: Change From Baseline in Breast Symptoms Scale as Assessed by the EORTC-QLQ-BR23
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.
Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)
Atlanta
Georgia
30322
United States
University of Kansas Cancer Center
Westwood
Kansas
66203
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02115
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
Tennessee Oncology (Sarah Cannon)
Nashville
Tennessee
37203
United States
MD Anderson
Houston
Texas
77030
United States
Institut Jules Bordet
Anderlecht
1070
Belgium
UZ Leuven
Leuven
3000
Belgium
The First Affiliated Hosptial of Bengbu Medical College
Bengbu
Anhui
233000
China
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
510060
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Guangdong
510289
China
Hunan Cancer Hospital
Changsha
Hunan
410000
China
Affliated Hospital of Jining Medical University
Jining
Shandong
272000
China
The Second People's Hospital of Neijiang
Neijiang
Sichuan
641100
China
Tianjing Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
300060
China
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
08035
Spain
START Madrid
Madrid
28050
Spain
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.
FG002
Part 1 Dose Escalation: Cohort 3
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.
FG003
Part 2 Stages 1 & 2
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.
FG004
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
FG005
Expansion Cohort B - ZEN003694 Monotherapy
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.
FG006
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
FG0006 subjects
FG0018 subjects
FG0023 subjects
FG00342 subjects
FG00421 subjects
FG0053 subjects
FG00632 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0006 subjects
FG0018 subjects
FG0023 subjects
FG00342 subjects
FG00421 subjects
FG0053 subjects
FG00632 subjects
Type
Comment
Reasons
Radiographic Progression
FG0004 subjects
FG0016 subjects
FG0023 subjects
FG00330 subjects
FG0047 subjects
FG0052 subjects
FG00611 subjects
Clinical Progression
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0037 subjects
FG004
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Termination of study by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not Reported
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
All treated safety population consisted of all treated participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 Dose Escalation: Cohort 1
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.
BG001
Part 1 Dose Escalation: Cohort 2
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.
BG002
Part 1 Dose Escalation: Cohort 3
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.
BG003
Part 2 Stages 1 & 2
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.
BG004
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
BG005
Expansion Cohort B - ZEN003694 Monotherapy
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.
BG006
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0018
BG0023
BG00342
BG00421
BG0053
BG00632
BG007115
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG0023
ParticipantsBG003
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
Height
Data not available for all study participants
Mean
Standard Deviation
cm
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
Height
Data not available for all study participants
Median
Full Range
cm
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
Weight
Median
Full Range
kg
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
BMI
Data not available for all study participants
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
BMI
Data not available for all study participants
Median
Full Range
kg/m^2
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0018
ParticipantsBG002
ECOG Performance Status
ECOG Performance Status
0 - Fully active, able to carry on all pre-disease performance without restriction
- 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)
- Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
- Dead
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1 and Part 2: Number of Participants With Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE)
Posted
Count of Participants
Participants
Cycle 1 Day 1 to 30 days post last dose (each cycle is 28 days) up to 22 months
ID
Title
Description
OG000
Part 1 Dose Escalation: Cohort 1
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.
OG001
Part 1 Dose Escalation: Cohort 2
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.
OG002
Part 1 Dose Escalation: Cohort 3
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.
OG003
Part 2 Stages 1 & 2
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.
Units
Counts
Participants
OG0006
OG0018
OG0023
OG003
Title
Denominators
Categories
Patients Reporting at least one TEAE related to study treatment
Title
Measurements
OG0006
OG0018
OG0023
OG003
Primary
Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
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.
Posted
Number
participants
Cycle 1, Up to 1 month
ID
Title
Description
OG000
Part 1 Dose Escalation: Cohort 1
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.
OG001
Part 1 Dose Escalation: Cohort 2
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.
OG002
Part 1 Dose Escalation: Cohort 3
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.
Primary
Part 2: Clinical Benefit Rate (CBR)
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
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.
Posted
Number
Percentage of participants
From screening up to 18 months
ID
Title
Description
OG000
Part 2 Stages 1 & 2
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.
Units
Counts
Participants
OG000
Primary
Expansion Cohort A: Objective Response Rate (ORR) by RECIST v1.1 (CR or PR)
Percentage of participants with a confirmed complete response (CR) or partial response (PR) by RECIST 1.1
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.
Posted
Number
Percentage of participants
From screening up to 18 months
ID
Title
Description
OG000
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
Units
Counts
Participants
OG000
Secondary
Part 1, Expansion Cohorts A and C: Clinical Benefit Rate (CBR)
Percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD ≥ 4 cycles) by RECIST 1.1
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.
Posted
Number
Percentage of participants
From screening up to 18 months
ID
Title
Description
OG000
Part 1 Dose Escalation - Cohort 1
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.
OG001
Part 1 Dose Escalation: Cohort 2
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.
OG002
Part 1 Dose Escalation: Cohort 3
Secondary
Part 1, Part 2, and Expansion Cohort C: Objective Response Rate (ORR)
Percentage of participants with a confirmed complete response (CR) or partial response (PR) by RECIST 1.1
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.
Posted
Number
Percentage of participants
From screening up to 18 months
ID
Title
Description
OG000
Part 1 Dose Escalation: Cohort 1
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.
OG001
Part 1 Dose Escalation: Cohort 2
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.
OG002
Part 1 Dose Escalation: Cohort 3
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.
Secondary
Part 2, Expansion Cohorts A and C: Safety Profile of ZEN003694 in Combination With Talazoparib.
Incidence of Treatment-related Adverse Events (AE) and Treatment-related Serious Adverse Events (SAE) in Part 2, Expansion Cohorts A and C
Posted
Count of Participants
Participants
From screening up to 18 months
ID
Title
Description
OG000
Part 2 Stages 1 & 2
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.
OG001
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
OG002
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
Secondary
Part 1, Part 2, Expansion Cohorts A & C: Evaluate Median Progression-free Survival
Median progression-free survival is the time from randomization to documented disease progression or death
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.
Posted
Median
95% Confidence Interval
months
From screening up to 18 months
ID
Title
Description
OG000
Part 1 Dose Escalation - Cohort 1
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.
OG001
Part 1 Dose Escalation: Cohort 2
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.
OG002
Part 1 Dose Escalation: Cohort 3
Secondary
Part 2, Expansion Cohorts A and C: Evaluate Duration of Response (DOR)
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.
Participants with a confirmed response of PR or CR are included for the duration of response analysis
Posted
Median
Full Range
months
From screening up to 18 months
ID
Title
Description
OG000
Part 2 Stages 1 & 2
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.
OG001
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
OG002
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
Secondary
Part 1 and Part 2: Measure the Pharmacokinetic Parameter (PK) of Cmax of ZEN003694 and ZEN003791 (Active Metabolite)
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.
Part 1 (All evaluable participants): C1D1; Parts 1 & 2 (All evaluable participants): C2D1
Posted
Geometric Mean
Standard Error
ng/ML
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)
ID
Title
Description
OG000
Part 1 Dose Escalation: Cohort 1
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.
OG001
Part 1 Dose Escalation: Cohort 2
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.
OG002
Part 1 Dose Escalation: Cohort 3
Secondary
Part 1 and Part 2: Measure the Pharmacokinetic (PK) Parameter of Combined AUC(0-4h or 0-8h) of ZEN003694 and ZEN003791 (Active Metabolite)
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.
Part 1 (All evaluable participants): C1D1; Parts 1 & 2 (All evaluable participants): C2D1
Posted
Geometric Mean
Standard Error
ng*h/mL
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)
ID
Title
Description
OG000
Part 1 Dose Escalation: Cohort 1
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.
OG001
Part 1 Dose Escalation: Cohort 2
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.
OG002
Secondary
Part 1 & 2: Measure Plasma Concentrations of Talazoparib.
Plasma concentrations of talazoparib will be measured.
Part 1 (All evaluable participants): C1D15; Parts 1 & 2 (All evaluable participants): C2D1 & C2D15
Posted
Mean
Standard Deviation
pg/mL
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)
ID
Title
Description
OG000
Part 1 Dose Escalation: Cohort 1
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.
OG001
Part 1 Dose Escalation: Cohort 2
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.
OG002
Part 1 Dose Escalation: Cohort 3
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.
Secondary
Expansion Cohorts A, B, and C: Measure Plasma Concentrations of ZEN003694 and the Active Metabolite ZEN003791.
Plasma concentrations of ZEN003694 and the active metabolite ZEN003791 will be measured.
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.
Posted
Mean
Standard Deviation
ng/mL
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)
ID
Title
Description
OG000
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
OG001
Expansion Cohort B - ZEN003694 Monotherapy
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.
Secondary
Expansion Cohorts A and C: Measure Plasma Concentrations of Talazoparib.
Plasma concentrations of talazoparib will be measured.
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.
Posted
Mean
Standard Deviation
pg/mL
Cycle 2 Day 1: Pre-dose, Cycle 2 Day 15: Pre-dose (each cycle is 28 days)
ID
Title
Description
OG000
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
OG001
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
Units
Counts
Secondary
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
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.
Not Posted
Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)
Participants
Secondary
Part 2, Expansion Cohorts A and C: Change From Baseline in Breast Symptoms Scale as Assessed by the EORTC-QLQ-BR23
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.
Not Posted
Screening and Day 1 of every 28-day Cycle, up to 18 months (Overall Duration)
Participants
Time Frame
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1 Dose Escalation: Cohort 1
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.
0
6
3
6
6
6
EG001
Part 1 Dose Escalation: Cohort 2
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.
0
8
2
8
8
8
EG002
Part 1 Dose Escalation: Cohort 3
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.
0
3
1
3
3
3
EG003
Part 2 Stages 1 & 2
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.
3
42
11
42
42
42
EG004
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
5
21
10
21
21
21
EG005
Expansion Cohort B - ZEN003694 Monotherapy
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.
0
3
0
3
2
3
EG006
Expansion Cohort B - ZEN003694 Combination
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.
0
1
0
1
1
1
EG007
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
1
32
14
32
32
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG0033 affected42 at risk
EG0040 affected21 at risk
EG0050 affected3 at risk
EG0060 affected1 at risk
EG0071 affected32 at risk
Cardiac Failure
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Disease progression
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Apraxia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected8 at risk
EG0022 affected3 at risk
EG0038 affected42 at risk
EG00410 affected21 at risk
EG0050 affected3 at risk
EG0060 affected1 at risk
EG00716 affected32 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected6 at risk
EG0011 affected8 at risk
EG0021 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Dyschromatopsia
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Photopsia
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected8 at risk
EG0021 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0013 affected8 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0021 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected6 at risk
EG0015 affected8 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0014 affected8 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected8 at risk
EG0021 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected6 at risk
EG0013 affected8 at risk
EG0021 affected3 at risk
EG003
Malaise
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected8 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected8 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected8 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0021 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected8 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0003 affected6 at risk
EG0014 affected8 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected8 at risk
EG0021 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected6 at risk
EG0013 affected8 at risk
EG0021 affected3 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected8 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected8 at risk
EG0021 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected8 at risk
EG0021 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected8 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected8 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected8 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected8 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Disclosure permission may only be granted upon sponsor review.
Patients reporting at least one Serious TEAE related to study treatment
Title
Measurements
OG0002
OG0011
OG0020
OG0034
Units
Counts
Participants
OG0006
OG0018
OG0023
Title
Denominators
Categories
Platelet count decreased
Title
Measurements
OG0001
OG0011
OG0020
Platelet count decreased/ Fatigue
Title
Measurements
OG0001
OG0010
OG0020
37
Title
Denominators
Categories
Title
Measurements
OG00032.4
14
Title
Denominators
Categories
Title
Measurements
OG0000
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.
OG003
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
OG004
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
Units
Counts
Participants
OG0006
OG0016
OG0023
OG00314
OG00418
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00166.7
OG00233.3
OG0030
OG00411.1
OG003
Part 2 Stages 1 & 2
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.
OG004
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
Units
Counts
Participants
OG0006
OG0016
OG0023
OG00337
OG00418
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00116.7
OG00233.3
OG00321.6
OG0045.6
Units
Counts
Participants
OG00041
OG00121
OG00232
Title
Denominators
Categories
Patients reporting at least one TEAE related to study treatment
Title
Measurements
OG00041
OG00119
OG00232
Patients reporting at least one Serious TEAE related to study treatment
Title
Measurements
OG0004
OG0011
OG00213
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.
OG003
Part 2 Stages 1 & 2
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.
OG004
Expansion Cohort A - Combination Treatment in Post-TROP2-ADC Patients
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.
OG005
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.
Units
Counts
Participants
OG0006
OG0016
OG0023
OG00337
OG00414
OG00518
Title
Denominators
Categories
Title
Measurements
OG0005.42(NA to 9.2)Insufficient sample size for software to calculate the lower confidence interval limit for median PFS
OG0015.06(NA to NA)Insufficient sample size for software to calculate the lower and upper confidence interval limit for median PFS
OG0021.51(NA to 14.62)Insufficient sample size for software to calculate the lower confidence interval limit for median PFS
OG0033.25(1.84 to 5.09)
OG0041.38(1.15 to 2.73)
OG0051.71(1.41 to 3.88)
Units
Counts
Participants
OG0008
OG0010
OG0021
Title
Denominators
Categories
Title
Measurements
OG0004.7(1.8 to 16.6)
OG0028.3
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.
OG003
Part 2 - Stages 1 and 2
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.
Units
Counts
Participants
OG0006
OG0018
OG0023
OG00328
Title
Denominators
Categories
Cycle 1 Day 1 - ZEN003694
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0030
Title
Measurements
OG000406± 166
OG001407± 104
OG002143± 119
Cycle 2 Day 1 - ZEN003694
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG00328
Cycle 1 Day 1 - ZEN003791
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0030
Cycle 2 Day 1 - ZEN003791
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG00328
Part 1 Dose Escalation: Cohort 3
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.
OG003
Part 2 - Stages 1 and 2
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.
Units
Counts
Participants
OG0006
OG0018
OG0023
OG00328
Title
Denominators
Categories
AUC(0-8h) Cycle 1 Day 1
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0030
Title
Measurements
OG0002680± 894
OG0012502± 994
OG0021013± 733
AUC(0-4h) Cycle 2 Day 1
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG00328
OG003
Part 2 - Stages 1 and 2
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.
Units
Counts
Participants
OG0006
OG0015
OG0023
OG00335
Title
Denominators
Categories
Cycle 1 Day 15 Pre-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0030
Title
Measurements
OG0004813.3± 2278.1
OG0014582± 1562.5
OG0025650± 2714.1
Cycle 2 Day 1 Pre-dose
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG00335
Cycle 2 Day 15 Pre-dose
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG00330
OG002
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve Patients
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.