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BReast cancer Ex vivo Anthracycline Sensitivity Test (BREAST)- Using ex vivo drug sensitivity tests to optimize breast cancer therapy in the future


- candidate number25681
- NTR NumberNTR6180
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-dec-2016
- Secondary IDsMEC16-600 Erasmus Medisch Centrum 
- Public TitleBReast cancer Ex vivo Anthracycline Sensitivity Test (BREAST)- Using ex vivo drug sensitivity tests to optimize breast cancer therapy in the future
- Scientific TitleBReast cancer Ex vivo Anthracycline Sensitivity Test (BREAST)- Using ex vivo drug sensitivity tests to optimize breast cancer therapy in the future
- ACRONYMBREAST
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria 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
- Exclusion criteria 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 12-dec-2016
- planned closingdate1-dec-2018
- Target number of participants20
- InterventionsNA
- Primary outcomeThe primary end point is the concordance between the ex vivo anthracycline sensitivity test and the in vivo response to anthracycline-based NAC on MRI.
- Secondary outcomeExplore whether the use of different cut-off values for the ex vivo anthracycline sensitivity assay could even better predict the in vivo anthracycline response.
- TimepointsNA
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. A. Jager
- CONTACT for SCIENTIFIC QUERIESDr. A. Jager
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Mrace Comittee, Erasmus MC
- Publications
- Brief summaryOptimal 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.
- Main changes (audit trail)
- RECORD21-dec-2016 - 5-mrt-2017


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