No registrations found.
ID
Source
Brief title
Health condition
Breast cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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.
Background summary
The 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.
Study objective
This 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.
Study design
na
Intervention
na
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6376 |
| NTR-old | NTR6560 |
| Other | : MEC17-213 Erasmus Medisch Centrum |