To determine the concordance between the ex vivo anthracycline sensitivity test and in vivo response to anthracycline-based NAC. Also, optimal cut-off values for the ex vivo anthracycline sensitivity assay are determined to carefully predict in vivo…
ID
Bron
Verkorte titel
Aandoening
Breast cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary end point is the concordance between the ex vivo anthracycline sensitivity test and the in vivo response to anthracycline-based NAC on MRI.
Achtergrond van het onderzoek
Optimal patient selection for treatments is of utmost importance and only possible if proper predictive tests exist. Therefore, within the BReast cancer Ex vivo Anthracycline Sensitivity Test (BREAST) study, we investigate the concordance between the ex vivo anthracycline sensitivity test and the in vivo response to anthracycline-based NAC on MRI. Before start of treatment, a tumor biopsy will be obtained on which the ex vivo sensitivity test will be performed. The predictive value of this test will become apparent by evaluating the concordance with in vivo response.
Doel van het onderzoek
To determine the concordance between the ex vivo anthracycline sensitivity test and in vivo response to anthracycline-based NAC. Also, optimal cut-off values for the ex vivo anthracycline sensitivity assay are determined to carefully predict in vivo anthracycline response.
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)
• Age ≥18 years
• WHO performance status 0 or 1
• Planned treatment with anthracycline-based NAC (either 3 courses of FEC or 4 courses of AC)
• Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Planned treatment with TAC (taxanes concomitant with anthracyclines) courses
• Current therapeutical 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 use in a prophylactic dose is allowed.
• Any psychological condition potentially hampering compliance with the study protocol
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5588 |
| NTR-old | NTR6180 |
| Ander register | : MEC16-600 Erasmus Medisch Centrum |