This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer. In summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the "right therapy for each individual patient". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,000
a medical test commonly performed by a surgeon or an interventional radiologist in order to collect tissues for examination; in this case from a metastatic lesion
Institut Jules Bordet
Brussels, Belgium
RECRUITINGCliniques Universitaires St-Luc
Brussels, Belgium
RECRUITINGGrand Hopital Charleroi
Charleroi, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
Metastatic Breast Cancer (MBC) understanding
To improve the understanding of locally recurrent/advanced BC and MBC by using high-throughput technologies on primary, metastatic, as well as plasma ctDNA samples, to explore tumor heterogeneity, clonal evolution and transcriptional changes associated with mutational and copy number variation (CNV) patterns.
Time frame: 1 year after end of acrrual
Identification of "exceptional responders" and "rapid progressors"; the outlier patients
To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomic data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol).
Time frame: 1 year after end of accrual and subsequently during follow up period of 10 years
Feasibility of implementing a global molecular screening platform for MBC
To provide evidence that can contribute in assessing the feasibility of implementing a global molecular screening platform of MBC
Time frame: 1 year after end of accrual
Patient identification to match with biomarker-driven clinical trials
To identify patients with candidate driver alterations in their tumors that can be matched to biomarker-driven clinical trials.
Time frame: on ongoing basis during 3 years' patient recruitment
Building new therapeutic hypotheses
To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).
Time frame: 1 year after end of accrual and subsequently during follow up period of 10 years
Patients' prognosis determination
To evaluate the prognostic relevance of genomic alterations detected in plasma ctDNA samples, tumor metastatic biopsies and archived primary tissue.
Time frame: 1 year after end of accrual and subsequently during follow up period of 10 years
Correlation between molecular alterations and standardly assessed efficacy endpoints
To correlate molecular alterations in patients with the efficacy endpoints (response rate, progression-free survival and overall survival).
Time frame: 1 year after end of accrual and subsequently during follow up period of 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHU de Liège
Liège, Belgium
ACTIVE_NOT_RECRUITINGClinique et Maternité Sainte-Elisabeth (CMSE - Namur)
Namur, Belgium
RECRUITINGKliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum
Essen, Germany
COMPLETEDFrauenkliniken Maistrasse-Innenstadt und Großhadern
München, Germany
ACTIVE_NOT_RECRUITINGLandspitali
Reykjavik, Iceland
ACTIVE_NOT_RECRUITINGOspedale degli Infermi - S.O.C.Oncologia
Biella, Italy
COMPLETED...and 42 more locations