NL-OMON45269RecruitingNot Applicable
ex vivo Repair Capacity (RECAP) in advanced breast cancer patients<br>(extension of the HRD pilot study) <br> - Repair Capacity (RECAP)
niversitair Medisch Centrum0 sites44 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •Breast cancer patients with local recurrent or distant metastases
- •The site of the tumor should be easy amendable for biopsy. NB: lung metastases (high risk of hematothorax) and bone metastases (not suitable for ex vivo HRD 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 <5x ULN in case a liver biopsy is planned
- •Platelets >100 x 10e9/L and INR <1.5, unless platelet/INR values are not necessary according to local protocols or after consent of the intervention radiologist for that particular site of biopsy (e.g. biopsy of the skin). Written informed consent
Exclusion Criteria
- •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. Use of low molecular weight heparin (LMWH) should be interrupted shortly before biopsy is scheduled, unless this is not necessary according to local protocols or after consent of the intervention radiologist.
- •Any psychological condition potentially hampering compliance with the study protocol
Investigators
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