Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tu… (NCT02401347) | Clinical Trial Compass
CompletedPhase 2
Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors
United States21 participantsStarted 2015-08
Plain-language summary
The aim of this single-arm phase 2 clinical trial is to evaluate the anti-cancer activity of Talazoparib (also known as BMN 673) in patients with advanced breast cancer with specific genetic or tumor genomic alterations. Patients with either triple-negative or HER2-negative breast cancer are eligible.
Who can participate
Age range18 Years
SexALL
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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 Tumors (RECIST) version 1.1
* Must have progressed on at least 1 prior chemotherapy regimen for the treatment of advanced breast cancer; there is no upper limit on the number of prior therapies
* If prior platinum agent (eg, carboplatin or cisplatin) has been administered, no evidence of progression, or within 8 weeks of stopping platinum treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); if liver function abnormalities are due to hepatic metastasis, then AST and ALT ≤ 5 x ULN
* Total serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's syndrome)
* Calculated creatinine clearance ≥ 30 mL/min or serum creatinine ≤ 1.5 mg/dL
* Hemoglobin ≥ 9.0 g/dL with last transfusion at least 14 days before day 1 of study drug
* Absolute neutrophil count (ANC) ≥ 1500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Able to take oral medications
* Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
* Sexually active patients of childbearing potential must be wil…