search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


ex vivo assessment of Repair Capacity (RECAP) in advanced breast cancer patients (extension of the HRD pilot study)


- candidate number27502
- NTR NumberNTR6560
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jul-2017
- Secondary IDsMEC17-213 Erasmus Medisch Centrum 
- Public Titleex vivo assessment of Repair Capacity (RECAP) in advanced breast cancer patients (extension of the HRD pilot study)
- Scientific Titleex vivo assessment of Repair Capacity (RECAP) in advanced breast cancer patients (extension of the HRD pilot study)
- ACRONYMRECAP
- hypothesisThis study will investigate whether within BR grade 3 ER/PR+ or HER2+ breast cancers the percentage of homologous recombination deficiency is substantially higher in metastatic lesions compared to primary breast cancers.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 29-jun-2017
- planned closingdate29-jun-2019
- Target number of participants44
- Interventionsna
- Primary outcomeThe percentage of biopsies from local recurrent or metastatic lesions showing HRD among patients with BR grade 3 ER/PR+ or HER2+ breast cancer.
- Secondary outcome- The percentage of biopsies from local recurrent or metastatic lesions showing HRD among the BR grade 3 ER/PR+ subgroup alone.
- The percentage of biopsies from local recurrent or metastatic lesions showing HRD among patients with BR grade grade 1/2 ER/PR+ breast cancers and TNBC.
- 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)
Alpe díHuZes Foundation
- Publications
- Brief summaryThe ex vivo assessment of Repair Capacity (RECAP) test in advanced breast cancer patients is an extension of the HRD pilot study. In previous studies we have investigated percentages of homologous recombination deficient (HRD) tumors on primary tumor samples as well as on biopsies of metastatic lesions within all subtypes of breast cancer. We observed that within the TNBC the percentage of HRD tumors was more or less similar in primary and metastatic breast cancer. Whereas, we found that within the BR grade 3 ER/PR+ or HER2+ breast cancers the percentage of HRD was higher in the metastatic lesions compared to another cohort of primary breast cancers. It is of the utmost importance to determine whether these observations are maintained when the HRD test is performed on more metastatic breast cancer patients. Therefore, we want to enlarge the group of BR grade 3 ER/PR+ metastatic breast cancers to prove that within the BR grade 3 ER/PR+ breast cancers the percentage of HRD is indeed significantly increased in the metastatic lesions compared to primary breast cancers. This could have great clinical implications, in terms of prognosis as well as therapeutically.
- Main changes (audit trail)
- RECORD5-jul-2017 - 5-aug-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl