AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
ConditionMetastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJules Bordet Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female or male ≥ 18 years with diagnosis of locally recurrent/advanced BC not amenable to treatment with curative intent or MBC who have not received more than 1 line of systemic therapy (any type) in the metastatic setting.
histopathology-confirmed TNBC as defined by ER <1% and HER2 negative following ASCO-CAP guidelines
ILC (either based on ILC morphology or negative E-cadherin expression confirmed by IHC). Mixed ILC/invasive ductal carcinoma are not eligible for the ILC cohort.
late relapse BC (any subtype). Late relapse is defined as a patient with a radiologic or histologic confirmation of advanced or MBC relapse > 10 years from the primary BC diagnosis.
Disqualifiers
The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting.
Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy.
Presence of severe hematopoietic, renal, and/or hepatic dysfunction, including but not restricted to albumin < 3 g/dl.
Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.
Trial design
Design model
Single group
Treatments tested in this trial
metastatic lesion biopsy
Procedure/Surgerya 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
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: metastatic lesion biopsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 acrrualSecondary outcomes
1
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 years2
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 accrual3
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 recruitment4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jules Bordet Institute
Lead sponsor
Frontier Science & Technology Research Foundation, Inc.
Collaborator
Source ClinicalTrials.gov