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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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 →Frequently asked questions
Is NCT03990896 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PARP inhibitor, platinum-based chemotherapy disqualifies patients from enrollment.
Does this trial require BRCA1?
Yes, BRCA1 deleterious mutation is a required biomarker for enrollment.
Does this trial require BRCA2?
Yes, BRCA2 deleterious mutation is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages