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

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 Overview

• Status: Suspended
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Procedure: metastatic lesion biopsy

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Brussels, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Charleroi, Belgium, 6000
    • Grand Hôpital Charleroi
  • Edegem, Belgium, 1000
    • UZA, Antwerp University Hospital
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • CHU de Liège
  • Namur, Belgium, 5000
    • Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)
  • Wilrijk, Belgium, 2610
    • Sint-Augustinus
• Germany
  • Düsseldorf, Germany, 40235
    • Luisenkrankenhaus
  • Essen, Germany, 45136
    • Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum
  • Freiburg, Germany
    • University Medical Center Freiburg
  • Luebeck, Germany
    • University of Schleswig-Holstein / Campus Luebeck
  • Offenbach, Germany, 63069
    • Sana Klinikum Offenbach
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg gGmbH
• Iceland
  • Reykjavík, Iceland, 101
    • Landspitali
• Italy
  • Biella, Italy
    • Ospedale degli Infermi - S.O.C.Oncologia
  • Bolzano, Italy, 39100
    • Ospedale di Bolzano - Oncologia Medica
  • Carpi, Italy
    • Ospedale Ramazzini di Carpi
  • Cremona, Italy
    • Az. Istituti Ospitalieri di Cremona
  • Genova, Italy, 16132
    • IRCCS AOU San Martino-IST
  • Legnago, Italy, 37045
    • ULSS 21 Legnago
  • Milano, Italy, 20141
    • Istituto Europeo Di Oncologia
  • Parma, Italy, 43126
    • UOC Oncologia Medica - AOU Parma
  • Pavia, Italy
    • Fondazione Salvatore Maugeri
  • Reggio Emilia, Italy
    • IRCCS Az Ospedaliera S.Maria Nuova
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Centre Hospitalier
• Poland
  • Warsaw, Poland
    • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
• Portugal
  • Lisboa, Portugal, 1400-038
    • Champalimaud Foundation
• Spain
  • A Coruña, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08028
    • Dr Rosell Oncology Institute, Quirón Dexeus University Hospital
  • Castellón, Spain, 12002
    • Consorcio Hospitalario Provincial de Castellón
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcantara
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Madrid, Spain, 28050
    • Centro Integral Oncologico Clara Campa
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncología
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
  • Jönköping, Sweden, 55185
    • Ryhov County Hospital
• Switzerland
  • Baden, Switzerland
    • Kantonsspital Baden
  • Bern, Switzerland
    • Inselspital Bern
  • Chur, Switzerland
    • Kantonsspital Graubuenden
  • Lucerne, Switzerland, 6003
    • Luzerner Kantonsspital, Division of Medical Oncology
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
  • Bristol, United Kingdom, BS2 8HW
    • University Hospitals Bristol NHS Foundation Trust
  • Cornwall, United Kingdom, TR1 3LJ
    • Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
  • Dundee, United Kingdom, DD1 9SY
    • NHS Tayside, Ninewells Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Edinburgh Cancer Centre - Western General Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • Manchester, United Kingdom
    • Christie NHS Foundation Trust
  • Nottingham, United Kingdom
    • Nottingham University Hospital NHS Trust
  • South Glamorgan, United Kingdom, CF15 7QZ
    • Velindre NHS Trust
  • Swansea, United Kingdom, SA2 8QA
    • Singleton Hospital - ABM University Health Board
  • Yeovil, Somerset, United Kingdom, BA21 4AT
    • Yeovil District Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Women or men with metastatic or locally relapsed breast cancer manageable with systemic therapy
2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
3. Written informed consent prior to enrollment into the program.
4. Patient aged ≥ 18 years
5. Patient agrees to provide archived primary tumor tissue
6. Patient agrees to provide newly collected metastatic lesions tissue samples (archived material up to 6 months is allowed provided both Formalin Fixed Paraffin Embedded (FFPE) block and Frozen Tissue are available and were collected from the same lesion at the same time)
7. Patient agrees to provide blood samples

Exclusion Criteria:

1. The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting
2. Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy
3. Patients with bone-only metastatic disease
4. Patients with brain-only metastatic disease, unless surgical excision is planned (in which case tissue will be collected for AURORA purpose)
5. Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI)
6. Platelet count<100 000/mm3, INR>1.5 (international normalized ratio; blood clotting time) , Albumin<30
7. 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
8. Any anti-VEGF (vascular endothelial growth factor) or anti-VEGFR (vascular endothelial growth factor receptor) treatment administered less than 4 weeks before new biopsy procedure or no appropriate wash-out period for patients on anticoagulation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: metastatic lesion biopsy; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastatic Breast Cancer (MBC) understanding	To improve the understanding of MBC by performing high coverage Targeted Gene Sequencing (TGS) and RNA sequencing on matched primary and metastatic 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Building new therapeutic hypotheses	To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).	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 tumor metastatic biopsies and archived primary tissue	1 year after end of accrual and subsequently during follow up period of 10 years
Identification of "exceptional responders" and "rapid progressors"; the outlier patients	To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomics data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol)	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	1 year after end of accrual
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) set forth in clinical study protocols.	1 year after end of accrual and subsequently during follow up period of 10 years
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.	on ongoing basis during 3 years' patient recruitment

Collaborators and Investigators

• Sponsor: Breast International Group
• Collaborators: Frontier Science & Technology Research Foundation, Inc.; Breast European Adjuvant Studies Team
• Investigators: Principal Investigator: Philippe Aftimos, MD, Institut Jules Bordet, Brussels, Belgium; Principal Investigator: Mafalda Oliveira, MD, University Hospital Vall d'Hebron,Barcelona, Catalonia, Spain

Publications and helpful links

Helpful Links

• sponsor's website

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): March 1, 2021
• Study Completion (Anticipated): March 1, 2031

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; biomarker; metastatic; exploratory; molecular screening; Aurora; targeted gene sequencing; molecular aberrations
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BIG 14-01; 1408-BCG (Other Identifier: EORTC); GBG 85 (Other Identifier: German Breast Cancer Group (GBG)); ICR-CTSU/2014/10050 (Other Identifier: The Institute of Cancer Research, UK)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No