Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02401347 | Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors | PHASE2 | COMPLETED | 21 | — | — | Aug 1, 2015 | Dec 1, 2022 | Feb 21, 2023 | 1 | United States |
Objective response (OR) is a common measure of benefit. OR is defined as the number of participants who achieved complete response (CR) or partial clinical (PR), per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (v1.1). RECIST Criteria are assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays, as follows: * CR = Disappearance of all target and non-target lesions * PR = ≥30% decrease in the sum of the long diameter of target lesions * OR = CR+PR * Stable disease (SD) = Small changes that do not meet any of the above criteria * Progressive disease (PD) = ≥20% increase in long diameter of target lesions, and/or the appearance of any new lesion(s) The outcome is expressed as the number of participants that achieved either CR or PR within 24 weeks of the start of treatment, a number without dispersion.
| Arm | Type | Description |
|---|---|---|
| Cohort A - Triple-negative Breast Cancer | EXPERIMENTAL | Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily. |
| Cohort B - HER2-negative solid tumor | EXPERIMENTAL | Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily. |
| Name | Type | Description |
|---|---|---|
| Talazoparib Tosylate | DRUG | Participants receive Talazoparib tosylate at 1 mg by mouth daily. |
INCLUSION CRITERIA: * No deleterious germline BRCA1 or BRCA2 mutation based on full sequencing and comprehensive rearrangement testing at an external reference laboratory; patients with variants of unknown significance will be eligible * Measurable disease per Response Evaluation Criteria In Solid ...