Feasibility ex vivo Homologous Recombination Deficiency (HRD) test in advanced breast cancer disease

Feasibility ex vivo Homologous Recombination Deficiency (HRD) test in advanced breast cancer disease - HRD test breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42167

Enrollment

Registered

2014-08-08

Start date

2015-02-13

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

breast carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Breast cancer patients with distant metastases who preferably are planned to receive systemic treatment (e.g. cisplatin, carboplatin, anthracyclins and alkylating agents), alone or in combination with other chemotherapeutic agents. • 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

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

Measure	Time frame
The ability of ex vivo assay for RAD51 IRIF formation (as a measure of homologous recombination deficiency (HRD)) in metastatic breast cancer lesions of different sites among advanced breast cancer patients before start of treatment with chemotherapy. The sites of metastatic lesions that will be investigated are: liver, lymph nodes, and subcutaneous lesions. For each localization, biopsies from at least 3 different patients will be collected.	—

Measure

Time frame

The ability of ex vivo assay for RAD51 IRIF formation (as a measure of homologous recombination deficiency (HRD)) in metastatic breast cancer lesions of different sites among advanced breast cancer patients before start of treatment with chemotherapy. The sites of metastatic lesions that will be investigated are: liver, lymph nodes, and subcutaneous lesions. For each localization, biopsies from at least 3 different patients will be collected.

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Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results