RecruitingNot ApplicableNCT02102165

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


Sponsor

Breast International Group

Enrollment

1,000 participants

Start Date

Apr 1, 2014

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is the AURORA study — a research program that collects tumor tissue and blood samples from people with advanced or metastatic breast cancer to analyze the genetic changes that drive the disease, with the goal of developing better, more personalized treatments. **You may be eligible if...** - You are 18 or older with advanced or metastatic breast cancer - You have not received more than one round of systemic (whole-body) treatment for the metastatic disease - You have a tumor site that can be safely biopsied - You have a good performance status (able to carry out daily activities) - For current enrollment: you have triple-negative breast cancer, invasive lobular carcinoma, or breast cancer that relapsed more than 10 years after original diagnosis **You may NOT be eligible if...** - You have already had two or more lines of systemic treatment for metastatic disease - You are unable to give informed consent - Your tumor cannot be biopsied Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREmetastatic 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


Locations(52)

Institut Jules Bordet

Brussels, Belgium

Cliniques Universitaires St-Luc

Brussels, Belgium

Grand Hopital Charleroi

Charleroi, Belgium

UZ Leuven

Leuven, Belgium

CHU de Liège

Liège, Belgium

Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)

Namur, Belgium

Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum

Essen, Germany

Frauenkliniken Maistrasse-Innenstadt und Großhadern

München, Germany

Landspitali

Reykjavik, Iceland

Ospedale degli Infermi - S.O.C.Oncologia

Biella, Italy

Ospedale di Bolzano - Oncologia Medica

Bolzano, Italy

Ospedale Ramazzini di Carpi

Carpi, Italy

IRCCS AOU San Martino-IST

Genova, Italy

ULSS 21 Legnago

Legnago, Italy

Istituto Europeo di Oncologia

Milan, Italy

UOC Oncologia Medica - AOU Parma

Parma, Italy

Fondazione Salvatore Maugeri

Pavia, Italy

IRCCS Az Ospedaliera S.Maria Nuova

Reggio Emilia, Italy

Centre Hospitalier

Luxembourg, Luxembourg

Champalimaud Foundation

Lisbon, Portugal

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital del Mar

Barcelona, Spain

Dr Rosell Oncology Institute, Quirón Dexeus University Hospital

Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Consorcio Hospitalario Provincial de Castellón

Castellon, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

MD Anderson Cancer Center

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Centro Integral Oncológico Clara Campa

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Instituto Valenciano de Oncología

Valencia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Sahlgrenska University Hospital

Gothenburg, Sweden

Ryhov County Hospital

Jönköping, Sweden

Kantonsspital Baden

Baden, Switzerland

Inselspital Bern

Bern, Switzerland

Kantonsspital Graubuenden

Chur, Switzerland

Luzerner Kantonsspital, Division of Medical Oncology

Lucerne, Switzerland

Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Velindre NHS Trust

Cardiff, United Kingdom

NHS Tayside, Ninewells Hospital

Dundee, United Kingdom

Edinburgh Cancer Centre - Western General Hospital

Edinburgh, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Christie NHS Foundation Trust

Manchester, United Kingdom

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

Singleton Hospital - ABM University Health Board

Swansea, United Kingdom

Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust

Truro, United Kingdom

Yeovil District Hospital NHS Foundation Trust

Yeovil, United Kingdom

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NCT02102165


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