Actively Recruiting
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test
Led by Erasmus Medical Center · Updated on 2025-02-28
66
Participants Needed
3
Research Sites
324 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- WHO performance status 0-2
- Locally advanced breast cancer without curative treatment options or metastatic breast cancer
- Documented progressive disease within 4 months before study entry
- Breast cancer must be either high grade ER positive (>10%) and HER2 negative, triple negative, or any grade/receptor status with HRD phenotype by RECAP test or BRCA1/2 mutation
- At least one metastatic lesion accessible for biopsy (excluding lung and bone metastases)
- HRD tumor confirmed by RECAP test before talazoparib treatment
- Maximum of four prior chemotherapy lines for advanced disease; patients with prior platinum treatment must have at least 4 months progression-free interval
- Measurable or evaluable disease per RECIST 1.1
- Life expectancy of at least 3 months
- Hemoglobin ≥ 10 g/dL and absolute neutrophil count ≥ 1.5 x 10⁹/L
- Platelets > 100 x 10⁹/L
- Liver function: total bilirubin ≤ 1.5 x ULN (except Gilbert's syndrome), AST and ALT < 3 x ULN or < 5 x ULN if liver metastasis
- Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Negative pregnancy test for females with childbearing potential
- Provided written informed consent
You will not qualify if you...
- Psychological conditions that may affect study compliance
- Treatment with investigational antitumor drugs within 28 days prior to first dose
- Chemotherapy within 21 days or weekly chemotherapy within 14 days prior to first dose
- Radiotherapy within 4 weeks prior to first dose except limited palliative doses
- Persistent grade 2 or higher toxicity from prior cancer therapy (except alopecia)
- Symptomatic brain or leptomeningeal metastases; asymptomatic patients after treatment may be eligible
- Positive pregnancy test or breastfeeding
- Unreliable contraceptive use; participants must use reliable contraception during the study
- Use of P-gp or BCRP inhibitors or inducers
- History of myelodysplastic syndrome or acute myeloid leukemia
- Uncontrolled infections including HIV or active hepatitis B/C
- Recent myocardial infarction (within 6 months) or unstable angina
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
2
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
3
Groningen University Medical Center
Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
C
Clinical Trial Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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