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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45269

Enrollment

Registered

2017-06-09

Start date

2017-06-29

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

breast carcinoma

Interventions

breast cancer

predictive test

homologous recombination

PARP

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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 100 x 10e9/L and 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. 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 outcomes

Primary

Measure	Time frame
The percentage of biopsies from local recurrent or metastatic lesions showing HRD among patients with BR grade 3 ER/PR+ or HER2+ primary breast cancer.	—

Secondary

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

Measure

Time frame

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

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)