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

NCT02102165 · Breast International Group
In plain English

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About this study
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
Inclusion Criteria: 1. 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. 2. Written informed consent prior to registration into the program. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. 4. Availability of primary tumor tissue for research purposes. 5. Patient must have a metastatic lesion accessible for biopsy and must agree with the biopsy procedure. 1. 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. 2. In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted provided that the chosen site of biopsy was not previously irradiated. 3. Brain tissue is accepted if it is obtained through surgical excision not planned for AURORA, but as part of the routine clinical practice. 6. 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. 7. 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. 8. Availability of a whole blood, serum and plasma samples collected at the time of screening. 9. Patient agrees to provide blood samples at regular intervals, from the screening as well as during the follow-up phase of the program. 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. Presence of severe hematopoietic, renal, and/or hepatic dysfunction, including but not restricted to albumin \< 3 g/dl. 4. Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician. 5. 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.
Study design
Enrollment target: 1000 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2014-04
Estimated completion: 2031-03
Last updated: 2025-07-16
Interventions
Procedure: metastatic lesion biopsy
Primary outcomes
  • Metastatic Breast Cancer (MBC) understanding (1 year after end of acrrual)
Sponsor
Breast International Group · other
With: Jules Bordet Institute, Frontier Science & Technology Research Foundation, Inc.
Contacts & investigators
ContactAURORA BIG HQ · contact · aurora.bighq@bigagainstbc.org
InvestigatorPhilippe Aftimos, MD · principal_investigator, Institut Jules Bordet, Brussels, Belgium
InvestigatorAngel Guerrero Zotano, MD · principal_investigator, Instituto Valenciano de Oncologia, Valencia, Spain
InvestigatorMatteo Benelli, PhD · principal_investigator, Breast International Group
All locations (52)
Institut Jules BordetRecruiting
Brussels, Belgium
Cliniques Universitaires St-LucRecruiting
Brussels, Belgium
Grand Hopital CharleroiRecruiting
Charleroi, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
CHU de LiègeActive Not Recruiting
Liège, Belgium
Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)Recruiting
Namur, Belgium
Kliniken Essen-Mitte, Klinik für Senologie/ BrustzentrumCompleted
Essen, Germany
Frauenkliniken Maistrasse-Innenstadt und GroßhadernActive Not Recruiting
München, Germany
LandspitaliActive Not Recruiting
Reykjavik, Iceland
Ospedale degli Infermi - S.O.C.OncologiaCompleted
Biella, Italy
Ospedale di Bolzano - Oncologia MedicaActive Not Recruiting
Bolzano, Italy
Ospedale Ramazzini di CarpiActive Not Recruiting
Carpi, Italy
IRCCS AOU San Martino-ISTActive Not Recruiting
Genova, Italy
ULSS 21 LegnagoActive Not Recruiting
Legnago, Italy
Istituto Europeo di OncologiaActive Not Recruiting
Milan, Italy
UOC Oncologia Medica - AOU ParmaActive Not Recruiting
Parma, Italy
Fondazione Salvatore MaugeriCompleted
Pavia, Italy
IRCCS Az Ospedaliera S.Maria NuovaActive Not Recruiting
Reggio Emilia, Italy
Centre HospitalierActive Not Recruiting
Luxembourg, Luxembourg
Champalimaud FoundationRecruiting
Lisbon, Portugal
Complexo Hospitalario Universitario A CoruñaRecruiting
A Coruña, Spain
Hospital del MarRecruiting
Barcelona, Spain
Dr Rosell Oncology Institute, Quirón Dexeus University HospitalActive Not Recruiting
Barcelona, Spain
Hospital Vall d'HebronActive Not Recruiting
Barcelona, Spain
Consorcio Hospitalario Provincial de CastellónCompleted
Castellon, Spain
Hospital San Pedro de AlcantaraActive Not Recruiting
Cáceres, Spain
Hospital Universitari Arnau de VilanovaActive Not Recruiting
Lleida, Spain
MD Anderson Cancer CenterActive Not Recruiting
Madrid, Spain
Hospital Clínico San CarlosRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreActive Not Recruiting
Madrid, Spain
Centro Integral Oncológico Clara CampaActive Not Recruiting
Madrid, Spain
Hospital Universitario Virgen del RocioCompleted
Seville, Spain
Instituto Valenciano de OncologíaRecruiting
Valencia, Spain
Hospital Clinico Universitario de ValenciaActive Not Recruiting
Valencia, Spain
Hospital General Universitario de ValenciaCompleted
Valencia, Spain
Sahlgrenska University HospitalActive Not Recruiting
Gothenburg, Sweden
Ryhov County HospitalActive Not Recruiting
Jönköping, Sweden
Kantonsspital BadenCompleted
Baden, Switzerland
Inselspital BernCompleted
Bern, Switzerland
Kantonsspital GraubuendenCompleted
Chur, Switzerland
Luzerner Kantonsspital, Division of Medical OncologyCompleted
Lucerne, Switzerland
Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation TrustActive Not Recruiting
Birmingham, United Kingdom
University Hospitals Bristol NHS Foundation TrustActive Not Recruiting
Bristol, United Kingdom
Velindre NHS TrustActive Not Recruiting
Cardiff, United Kingdom
NHS Tayside, Ninewells HospitalActive Not Recruiting
Dundee, United Kingdom
Edinburgh Cancer Centre - Western General HospitalActive Not Recruiting
Edinburgh, United Kingdom
Beatson West of Scotland Cancer CentreActive Not Recruiting
Glasgow, United Kingdom
Christie NHS Foundation TrustActive Not Recruiting
Manchester, United Kingdom
Nottingham University Hospital NHS TrustActive Not Recruiting
Nottingham, United Kingdom
Singleton Hospital - ABM University Health BoardActive Not Recruiting
Swansea, United Kingdom
Royal Cornwall Hospital - Royal Cornwall Hospitals NHS TrustActive Not Recruiting
Truro, United Kingdom
Yeovil District Hospital NHS Foundation TrustActive Not Recruiting
Yeovil, United Kingdom