This study will investigate the feasibility of HRD test in metastatic lesions of different sites among breast cancer patients who will start treatment with chemotherapy. The sites of metastatic lesions that will be investigated are: liver, lymph…
ID
Bron
Verkorte titel
Aandoening
Defective homologous recombination DNA repair imposed by BRCA1 or BRCA2 gene deficiencies sensitizes cells to double strand break (DSB)-inducing DNA damaging agents like platinum derivates and anthracyclines. The formation of RAD51 IRIF is impaired in BRCA1 or BRCA2 defective cells and also in other genetic defects leading to HR deficiency. In current healthcare these anti-cancer agents e.g. platinum derivates are usually administered at late stage of advanced breast cancer from which only a subpopulation of patients benefit from the treatment. Having a test that can predict whether or not an individual patient could benefit from the treatment will provide the option to provide the treatment at an earlier stage of the disease.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
the proportion of patients with a useful test result (Putest)
will be considered as the primary end point
Doel van het onderzoek
This study will investigate the feasibility of HRD test in metastatic lesions of different sites among breast cancer patients who will start treatment with chemotherapy. The sites of metastatic lesions that will be investigated are: liver, lymph nodes, and subcutaneous lesions.
Onderzoeksopzet
na
Onderzoeksproduct en/of interventie
na
Publiek
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
Wetenschappelijk
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5447 |
| NTR-old | NTR5574 |
| Ander register | Erasmus Medisch Centrum : MEC14-295 |