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Feasibility ex vivo Homologous Recombination Deficiency (HRD) test in advanced breast cancer disease: a pilot study

Feasibility ex vivo Homologous Recombination Deficiency (HRD) test in advanced breast cancer disease: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24673
Enrollment
Unknown
Registered
2015-11-20
Start date
2015-02-13
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defective homologous recombination DNA repair imposed by BRCA1 or BRCA2 gene deficiencies sensitizes cells to double strand break (DSB)-inducing DNA damaging agents like platinum derivates and anthracyclines. The formation of RAD51 IRIF is impaired in BRCA1 or BRCA2 defective cells and also in other genetic defects leading to HR deficiency. In current healthcare these anti-cancer agents e.g. platinum derivates are usually administered at late stage of advanced breast cancer from which only a sub

Interventions

None listed

Sponsors

Erasmus MC, Cancer Institute, department of Medical Oncology, Rotterdam.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • The site of the tumor should be amendable for biopsy. NB lung metastases (high risk of hematothorax) and bone metastases (not suitable for ex vivo test because calcifications interfere with experimental procedures) are excluded. • Age >18 years • WHO performance status 0 or 1 • Bilirubin 100 x 10e9/L • INR <1.5 • Written informed consent

Exclusion criteria

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. • Any psychological condition potentially hampering compliance with the study protocol

Design outcomes

Primary

MeasureTime frame
the proportion of patients with a useful test result (Putest) will be considered as the primary end point

Contacts

Public ContactA. Jager

Erasmus MC, Room 471

a.jager@erasmusmc.nlTel 010 704 17 33

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)