Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28235
Enrollment
44
Registered
2017-07-05
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 cancer

Interventions

None listed

Sponsors

Erasmus Medisch Centrum
Lead Sponsor

Eligibility

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 <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

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

MeasureTime frame
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

MeasureTime frame
- 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.

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)