Feasibility ex vivo Homologous Recombination Deficiency (HRD) test in advanced breast cancer disease
- Conditions
- breast carcinoma10006291
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 43
• Breast cancer patients with distant metastases who preferably are planned to receive systemic treatment (e.g. cisplatin, carboplatin, anthracyclins and alkylating agents), alone or in combination with other chemotherapeutic agents.
• The site of the tumor should be amendable for biopsy. NB lung metastases (high risk of hematothorax) and bone metastases (not suitable for ex vivo test because calcifications interfere with experimental procedures) are excluded.
• Age > 18 years
• WHO performance status 0 or 1
• Bilirubin <1.5 ULN and both AST and ALT <2,5x ULN in case a liver biopsy is planned
• Platelets > 100 x 10e9/L
• INR <1.5
• Written informed consent
• Current therapeutically use of anti-coagulant (coumarin derivates, warfarin, heparin or low molecular weight heparin [LMWH]) whereby a short interruption of drug use is not allowed. LMWH if used for prophylaxis is allowed.
• Any psychological condition potentially hampering compliance with the study protocol
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The ability of ex vivo assay for RAD51 IRIF formation (as a measure of<br /><br>homologous recombination deficiency (HRD)) in metastatic breast cancer lesions<br /><br>of different sites among advanced breast cancer patients before start of<br /><br>treatment with chemotherapy. The sites of metastatic lesions that will be<br /><br>investigated are: liver, lymph nodes, and subcutaneous lesions. For each<br /><br>localization, biopsies from at least 3 different patients will be collected.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-</p><br>