OncoMatch/Clinical Trials/NCT06193525
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test
Is NCT06193525 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Talazoparib for advanced breast cancer.
Treatment: Talazoparib — The goal of this clinical trial is to prove that the RECAP test is capable of selecting advanced breast cancer patients sensitive for treatment with the PARP inhibitor talazoparib. Participants will undergo an ultrasound-guided biopsy and a blood withdrawal. Homologous Recombination (HR) deficient patients (approximately 30%) can start talazoparib treatment until progression of the disease or unacceptable side-effects and their response will be evaluated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: BRCA1 germline or somatic mutation
Required: BRCA2 germline or somatic mutation
Disease stage
Grade: bloom & richardson grade 3 (for er+ her2- subtype) (bloom & richardson)
Performance status
WHO 0–2
Prior therapy
Cannot have received: investigational antitumor drugs
Any treatment with investigational antitumor drugs within 28 days prior to receiving the first dose of investigational treatment
Cannot have received: standard chemotherapy
within 21 days for standard chemotherapy
Cannot have received: weekly scheduled chemotherapeutic regimens or endocrine therapy
within 14 days for weekly scheduled chemotherapeutic regimens or endocrine therapy
Cannot have received: radiation therapy
Exception: except 1 or 2 x 8 Gy for pain palliation, then seven days interval after the last radiation should be maintained
Radiotherapy within the last four weeks prior to receiving the first dose of investigational treatment
Lab requirements
Blood counts
Hemoglobin ≥ 10 g/dL (6,2 mmol/L) and ANC of ≥ 1.5 x 10^9 /L; Platelets >100 x 10e9/L
Kidney function
serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula)
Liver function
Bilirubin <1.5 ULN (except elevated bilirubin due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin) and both AST and ALT <5x ULN in case a liver biopsy is planned. Hepatic function as defined by total serum bilirubin ≤ 1.5 x ULN (except elevated bilirubin due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin), ASAT and ALAT < 3 x ULN or <5 x ULN in case of liver metastasis
Hemoglobin ≥ 10 g/dL (6,2 mmol/L) and ANC of ≥ 1.5 x 10^9 /L; Platelets >100 x 10e9/L; Bilirubin <1.5 ULN (except elevated bilirubin due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin) and both AST and ALT <5x ULN in case a liver biopsy is planned. Hepatic function as defined by total serum bilirubin ≤ 1.5 x ULN (except elevated bilirubin due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin), ASAT and ALAT < 3 x ULN or <5 x ULN in case of liver metastasis. Adequate renal function as defined by either serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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