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

Recruiting

Conditions: breast carcinoma
10006291

Registration Number: NL-OMON45269

Lead Sponsor: niversitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 44

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of biopsies from local recurrent or metastatic lesions showing<br /><br>HRD among patients with BR grade 3 ER/PR+ or HER2+ primary breast cancer. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To explore that the percentage of HRD is higher in the ER/PR+ grade 3 subgroup<br /><br>compared to other subgroups.<br /><br><br /><br>To explore that within TNBC and grade 1 or 2 ER/PR+ breast cancers the<br /><br>percentage of HRD is not substantially increased in the metastatic lesions<br /><br>compared to primary breast cancers.<br /><br><br /><br>Molecular analysis will be performed to determine if a general molecular<br /><br>denominator can be found within the HRD versus the non-HRD group.<br /><br><br /><br>An attempt will be made to grow organoids from the biopsies to expand the<br /><br>limited amount of starting material in order to perform additional molecular<br /><br>analyses. </p><br>