AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.

NCT02102165 | Recruiting DMC

• 4 other identifiers: BIG 14-011408-BCGGBG 85ICR-CTSU/2014/10050
• Study Type: interventional
• Target: 1,000
• Locations: 10 countries
• Sites: 52

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

Aurora; breast cancer; metastatic; molecular screening; targeted gene sequencing; molecular aberrations; exploratory; biomarker

Outcome Measures

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.

  1 year after end of acrrual

Secondary Outcomes (6)

• Identification of "exceptional responders" and "rapid progressors"; the outlier patients

  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

  1 year after end of accrual

• Patient identification to match with biomarker-driven clinical trials

  on ongoing basis during 3 years' patient recruitment

• Building new therapeutic hypotheses

  1 year after end of accrual and subsequently during follow up period of 10 years

• Patients' prognosis determination

  1 year after end of accrual and subsequently during follow up period of 10 years

Study Arms (1)

metastatic lesion biopsy

EXPERIMENTAL

biopsy of metastatic lesion will be performed at program inclusion or maximum 6 months prior to inclusion. Sample of primary tumor must be available at inclusion.

Procedure: metastatic lesion biopsy

Interventions

metastatic lesion biopsy PROCEDURE

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

metastatic lesion biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Under protocol 4.0, eligible patients will be limited to locally recurrent/advanced breast cancer not amenable to treatment with curative intent or MBC with:
• 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.
• Written informed consent prior to registration into the program.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Availability of primary tumor tissue for research purposes.
• Patient must have a metastatic lesion accessible for biopsy and must agree with the biopsy procedure.
• Up until protocol 3.0, up to 100 patients with bone-only metastasis have been included without a metastatic biopsy, if plasma samples have been collected at screening, and if the patient met all other eligibility criteria.
• In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted provided that the chosen site of biopsy was not previously irradiated.
• Brain tissue is accepted if it is obtained through surgical excision not planned for AURORA, but as part of the routine clinical practice.
• The biopsy of the metastatic lesion must be conducted either at the initial diagnosis of the BC relapse before the initiation of 1st line systemic therapy or at the 1st disease progression before initiation of a second line systemic treatment. There is no restriction in the type of therapeutic modality considered as 1st line systemic treatment, which can consist of any type of treatment administered after the diagnosis of the advanced BC relapse till the 1st disease progression thereafter.
• Biopsies obtained during routine clinical practice are accepted if both formalin-fixed paraffin-embedded (FFPE) and Frozen Tissue (FT) blocks were collected concurrently from the same metastatic lesion and if collected at the pre-specified timelines for AURORA.
• Availability of a whole blood, serum and plasma samples collected at the time of screening.

You may not qualify if:

• 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.
• Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Breast International Group: lead
• Jules Bordet Institute: collaborator
• Frontier Science & Technology Research Foundation, Inc.: collaborator

Study Sites (52)

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

RECRUITING

Grand Hopital Charleroi

Charleroi, 6000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

CHU de Liège

Liège, 4000, Belgium

ACTIVE NOT RECRUITING

Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)

Namur, 5000, Belgium

RECRUITING

Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum

Essen, 45136, Germany

COMPLETED

Frauenkliniken Maistrasse-Innenstadt und Großhadern

München, 80336, Germany

ACTIVE NOT RECRUITING

Landspitali

Reykjavik, 101, Iceland

ACTIVE NOT RECRUITING

Ospedale degli Infermi - S.O.C.Oncologia

Biella, Italy

COMPLETED

Ospedale di Bolzano - Oncologia Medica

Bolzano, 39100, Italy

ACTIVE NOT RECRUITING

Ospedale Ramazzini di Carpi

Carpi, Italy

ACTIVE NOT RECRUITING

IRCCS AOU San Martino-IST

Genova, 16132, Italy

ACTIVE NOT RECRUITING

ULSS 21 Legnago

Legnago, 37045, Italy

ACTIVE NOT RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

ACTIVE NOT RECRUITING

UOC Oncologia Medica - AOU Parma

Parma, 43126, Italy

ACTIVE NOT RECRUITING

Fondazione Salvatore Maugeri

Pavia, Italy

COMPLETED

IRCCS Az Ospedaliera S.Maria Nuova

Reggio Emilia, Italy

ACTIVE NOT RECRUITING

Centre Hospitalier

Luxembourg, 1210, Luxembourg

ACTIVE NOT RECRUITING

Champalimaud Foundation

Lisbon, 1400-038, Portugal

RECRUITING

Complexo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Dr Rosell Oncology Institute, Quirón Dexeus University Hospital

Barcelona, 08028, Spain

ACTIVE NOT RECRUITING

Hospital Vall d'Hebron

Barcelona, 08035, Spain

ACTIVE NOT RECRUITING

Consorcio Hospitalario Provincial de Castellón

Castellon, 12002, Spain

COMPLETED

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

ACTIVE NOT RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

ACTIVE NOT RECRUITING

MD Anderson Cancer Center

Madrid, 28033, Spain

ACTIVE NOT RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

ACTIVE NOT RECRUITING

Centro Integral Oncológico Clara Campa

Madrid, 28050, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

COMPLETED

Instituto Valenciano de Oncología

Valencia, 46009, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

ACTIVE NOT RECRUITING

Hospital General Universitario de Valencia

Valencia, 46014, Spain

COMPLETED

Sahlgrenska University Hospital

Gothenburg, Sweden

ACTIVE NOT RECRUITING

Ryhov County Hospital

Jönköping, 55185, Sweden

ACTIVE NOT RECRUITING

Kantonsspital Baden

Baden, Switzerland

COMPLETED

Inselspital Bern

Bern, Switzerland

COMPLETED

Kantonsspital Graubuenden

Chur, Switzerland

COMPLETED

Luzerner Kantonsspital, Division of Medical Oncology

Lucerne, 6003, Switzerland

COMPLETED

Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

ACTIVE NOT RECRUITING

University Hospitals Bristol NHS Foundation Trust

Bristol, BS2 8HW, United Kingdom

ACTIVE NOT RECRUITING

Velindre NHS Trust

Cardiff, CF15 7QZ, United Kingdom

ACTIVE NOT RECRUITING

NHS Tayside, Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

ACTIVE NOT RECRUITING

Edinburgh Cancer Centre - Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

ACTIVE NOT RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

ACTIVE NOT RECRUITING

Christie NHS Foundation Trust

Manchester, United Kingdom

ACTIVE NOT RECRUITING

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

ACTIVE NOT RECRUITING

Singleton Hospital - ABM University Health Board

Swansea, SA2 8QA, United Kingdom

ACTIVE NOT RECRUITING

Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust

Truro, TR1 3LJ, United Kingdom

ACTIVE NOT RECRUITING

Yeovil District Hospital NHS Foundation Trust

Yeovil, BA21 4AT, United Kingdom

ACTIVE NOT RECRUITING

Related Links

• sponsor's website

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Aftimos, MD

  Institut Jules Bordet, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

• Angel Guerrero Zotano, MD

  Instituto Valenciano de Oncologia, Valencia, Spain

  PRINCIPAL INVESTIGATOR

• Matteo Benelli, PhD

  Breast International Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AURORA BIG HQ

CONTACT

aurora.bighq@bigagainstbc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: April 2, 2014
• Study Start: April 1, 2014
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15); IC (1); GB (11); CH (4); IT (9); BE (6); SE (2); DE (2); LU (1); PT (1)