Breast Cancer
Conditions
Interventions
None listed
Sponsors
EORTC
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - No tissue (or only cytology) available of the relapsed site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Methods: • Massive Parallel Sequencing of primary and relapse • Whole-genome DNA-sequencing to detect somatic copy numbers, rearrangements and mutations at a genome-wide level. • Transcriptonne seqyencing to detect RNA expression at a genonne-wide level. • Comparison of histology, grade, ER, PgR, HER2 and Ki67 status with the respective analysis results of the primary tumours using the same technologies as applied on the primary tumour samples performed at the MINDACT central pathology facility. • Evaluation of blood circulating DNA by custom based Massive Parallel Sequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival and any further disease progression | — |
Contacts
Public ContactJosephine Lopes Cardozo
Antoni van Leeuwenhoek ziekenhuis / Netherlands Cancer Institute
Outcome results
None listed