OncoMatch/Clinical Trials/NCT03990896
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
Is NCT03990896 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Talazoparib for breast cancer.
Treatment: Talazoparib — This research is to evaluate the effectiveness of Talazoparib as a potential treatment for metastatic breast cancer with a BRCA 1 or BRCA 2 mutation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: BRCA1 deleterious mutation
deleterious somatic BRCA 1 or 2 mutations detectable by cell-free circulating tumor DNA, by CLIA certified clinical assay
Required: BRCA2 deleterious mutation
deleterious somatic BRCA 1 or 2 mutations detectable by cell-free circulating tumor DNA, by CLIA certified clinical assay
Disease stage
Metastatic disease required
Metastatic breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — metastatic
disease progression on at least one prior chemotherapy regimen in the metastatic setting
Must have received: endocrine therapy — metastatic
disease progression on at least one prior endocrine therapy in the metastatic setting or be considered inappropriate for endocrine therapy
Cannot have received: PARP inhibitor
Patients must not have received prior treatment with a PARP inhibitor
Cannot have received: platinum-based chemotherapy
Exception: patient must not have progressed while on platinum treatment (any setting), or within 6 months after end of treatment (neoadjuvant and/or adjuvant)
Patients may have received prior platinum based chemotherapy (0-1 prior platinum based therapy). However, the patient must not have progressed while on platinum treatment (any setting), or within 6 months after end of treatment (neoadjuvant and/or adjuvant).
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1,500 /mcL; Platelets ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
Kidney function
Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X institutional upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Liver function
Serum total bilirubin ≤ 1.5 X institutional ULN OR Direct bilirubin ≤ institutional ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 X institutional ULN OR ≤ 5 X institutional ULN for subjects with liver metastases
Adequate organ function as defined in Table 1 within 10 days prior to treatment initiation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSF Medical Center-Mission Bay/Benioff Children's Hospital · San Francisco, California
- Emory University Winship Cancer Institute · Atlanta, Georgia
- Northwestern University · Chicago, Illinois
- Massachusetts General Hospital Cancer Center · Boston, Massachusetts
- Weill Cornell Medicine · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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