FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test
NCT06193525 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2025-02-28
Summary
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.
Conditions
Interventions
- DRUG
-
Talazoparib
Talazoparib is administered daily as single agent, 1 mg orally until unacceptable toxicity or progression of disease.
Sponsors & Collaborators
-
Leiden University Medical Center
collaborator OTHER -
University Medical Center Groningen
collaborator OTHER - lead OTHER
Principal Investigators
-
Agnes Jager, MD, PhD · Erasmus Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-16
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Netherlands
Study Locations
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