Dissecting the pathways of endocrine and chemotherapy resistance in breast cancer:A translational research project of the EORTC 10041/BIG 3-04 MINDACT clinical trial
- Conditions
- Breast Cancer
- Registration Number
- NL-OMON25567
- Lead Sponsor
- EORTC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 123
Retrospective part:
• Written informed consent of agreement for participating in the research project.
• Patients must have been enrolled in the MINDACT study and received randomized or non-randomized
treatment within the study, of any type and any duration, and have consented to future research or
are willing to provide consent for use of the primary tumour sample.
• Patients must have a local, regional or distant breast cancer relapse or new primary breast cancer
lesion and have undergone a bioptic/excision procedure of the new, not previously irradiated, lesion
as part of routine clinical practice before initiation of a subsequent line of systemic treatment (any
line).
• At least one Formalin-Fixed Paraffin-embedded (FFPE) tissue block or fresh-frozen tissue (FFT) from
the biopsy or from the resection specimen of the relapsed or new primary disease site, available for
translational research purposes.
• If blood or normal tissue is available in the hospital, it will be collected as well. For clarity, if normal
tissue is not available, patients remain eligible for the research project but will not be prioritized for
the molecular analysis.
• Biopsies of bone lesions are accepted if no other metastatic lesions are available.
• Patients with brain metastases are accepted if brain-tissue is provided through surgical excision as
part of the routine clinical practice.
MINDACT patients who participated in similar international (e.g. AURORA) or national programs (e.g.
SAFIR) and have Next Generation Sequencing (NGS) results available through these projects for the
primary and relapse tissue can still participate in the retrospective part by sending us any leftover
material from the relapse biopsy to perform new analysis or share the NGS reports with us, after
relevant agreement of the Steering Committee (or an equal governing body) of the respective project.
Prospective part:
• Written informed consent of agreement for participating in the research project.
• Patients must have been enrolled in the MINDACT study and received randomized or non-randomized
treatment within the study, of any type and any duration, and have consented to future research or
are willing to provide consent for use of the primary tumour sample.
• Patients must have a new diagnosis of local, regional or distant breast cancer relapse or new primary
breast cancer lesion based on physical, radiological and/or laboratory evaluation, and will undergo a
biopsy of this new, not previously irradiated, lesion as part of routine clinical practice.
• The biopsy of the local, regional or distant breast cancer relapse or new primary breast cancer lesion
must be conducted either at the initial diagnosis of the BC relapse or at the first disease progression
upon any line of systemic treatment received. Of note, the biopsy of the metastatic lesion must be
conducted before initiation of a subsequent line of systemic treatment.
• At least one FFPE tissue block or FFT from the biopsy or from the resection specimen of the relapsed
or new primary disease site, available for translational research purposes.
• If blood or normal tissue is available in the hospital, it will be collected as well. For clarity, if normal
tissue is not available, patients remain eligible for the research project but will not be prioritized for
the molecular analysis.
• Biopsies of bone lesions are accepted if no other metastatic lesions are available.
• Patients with brain metastases are accepted if brain-tissu
- No tissue (or only cytology) available of the relapsed site
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method