Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02102165

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

Led by Breast International Group · Updated on 2025-07-16

1000

Participants Needed

52

Research Sites

882 weeks

Total Duration

On this page

Sponsors

B

Breast International Group

Lead Sponsor

J

Jules Bordet Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Female or male 18 years or older with locally recurrent/advanced breast cancer not curable or metastatic breast cancer
  • No more than one line of systemic therapy in the metastatic setting
  • Histopathology-confirmed triple-negative breast cancer or invasive lobular carcinoma eligible under protocol 4.0
  • Late relapse breast cancer defined as relapse more than 10 years after primary diagnosis
  • Written informed consent provided
  • ECOG Performance Status of 0 or 1
  • Availability of primary tumor tissue for research
  • Metastatic lesion accessible for biopsy and agreement with biopsy procedure
  • Biopsy performed before starting first or second line systemic therapy
  • Availability of blood, serum, and plasma samples at screening
  • Agreement to provide blood samples regularly during follow-up
Not Eligible

You will not qualify if you...

  • More than one line of systemic therapy received in metastatic setting
  • Prior palliative radiotherapy to the only biopsy-accessible site
  • Severe blood, kidney, or liver dysfunction including albumin less than 3 g/dl
  • Increased risk of bleeding during biopsy as judged by physician
  • Other malignancies within last 5 years except treated in situ cervical carcinoma or treated basal/squamous cell skin carcinoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 52 locations

1

Institut Jules Bordet

Brussels, Belgium, 1000

Actively Recruiting

2

Cliniques Universitaires St-Luc

Brussels, Belgium, 1200

Actively Recruiting

3

Grand Hopital Charleroi

Charleroi, Belgium, 6000

Actively Recruiting

4

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

5

CHU de Liège

Liège, Belgium, 4000

Active, Not Recruiting

6

Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)

Namur, Belgium, 5000

Actively Recruiting

7

Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum

Essen, Germany, 45136

Completed

8

Frauenkliniken Maistrasse-Innenstadt und Großhadern

München, Germany, 80336

Active, Not Recruiting

9

Landspitali

Reykjavik, Iceland, 101

Active, Not Recruiting

10

Ospedale degli Infermi - S.O.C.Oncologia

Biella, Italy

Completed

11

Ospedale di Bolzano - Oncologia Medica

Bolzano, Italy, 39100

Active, Not Recruiting

12

Ospedale Ramazzini di Carpi

Carpi, Italy

Active, Not Recruiting

13

IRCCS AOU San Martino-IST

Genova, Italy, 16132

Active, Not Recruiting

14

ULSS 21 Legnago

Legnago, Italy, 37045

Active, Not Recruiting

15

Istituto Europeo di Oncologia

Milan, Italy, 20141

Active, Not Recruiting

16

UOC Oncologia Medica - AOU Parma

Parma, Italy, 43126

Active, Not Recruiting

17

Fondazione Salvatore Maugeri

Pavia, Italy

Completed

18

IRCCS Az Ospedaliera S.Maria Nuova

Reggio Emilia, Italy

Active, Not Recruiting

19

Centre Hospitalier

Luxembourg, Luxembourg, 1210

Active, Not Recruiting

20

Champalimaud Foundation

Lisbon, Portugal, 1400-038

Actively Recruiting

21

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

Actively Recruiting

22

Hospital del Mar

Barcelona, Spain, 08003

Actively Recruiting

23

Dr Rosell Oncology Institute, Quirón Dexeus University Hospital

Barcelona, Spain, 08028

Active, Not Recruiting

24

Hospital Vall d'Hebron

Barcelona, Spain, 08035

Active, Not Recruiting

25

Consorcio Hospitalario Provincial de Castellón

Castellon, Spain, 12002

Completed

26

Hospital San Pedro de Alcantara

Cáceres, Spain, 10003

Active, Not Recruiting

27

Hospital Universitari Arnau de Vilanova

Lleida, Spain, 25198

Active, Not Recruiting

28

MD Anderson Cancer Center

Madrid, Spain, 28033

Active, Not Recruiting

29

Hospital Clínico San Carlos

Madrid, Spain, 28040

Actively Recruiting

30

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Active, Not Recruiting

31

Centro Integral Oncológico Clara Campa

Madrid, Spain, 28050

Active, Not Recruiting

32

Hospital Universitario Virgen del Rocio

Seville, Spain, 41013

Completed

33

Instituto Valenciano de Oncología

Valencia, Spain, 46009

Actively Recruiting

34

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Active, Not Recruiting

35

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Completed

36

Sahlgrenska University Hospital

Gothenburg, Sweden

Active, Not Recruiting

37

Ryhov County Hospital

Jönköping, Sweden, 55185

Active, Not Recruiting

38

Kantonsspital Baden

Baden, Switzerland

Completed

39

Inselspital Bern

Bern, Switzerland

Completed

40

Kantonsspital Graubuenden

Chur, Switzerland

Completed

41

Luzerner Kantonsspital, Division of Medical Oncology

Lucerne, Switzerland, 6003

Completed

42

Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B15 2TH

Active, Not Recruiting

43

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom, BS2 8HW

Active, Not Recruiting

44

Velindre NHS Trust

Cardiff, United Kingdom, CF15 7QZ

Active, Not Recruiting

45

NHS Tayside, Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

Active, Not Recruiting

46

Edinburgh Cancer Centre - Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Active, Not Recruiting

47

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN

Active, Not Recruiting

48

Christie NHS Foundation Trust

Manchester, United Kingdom

Active, Not Recruiting

49

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

Active, Not Recruiting

50

Singleton Hospital - ABM University Health Board

Swansea, United Kingdom, SA2 8QA

Active, Not Recruiting

51

Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust

Truro, United Kingdom, TR1 3LJ

Active, Not Recruiting

52

Yeovil District Hospital NHS Foundation Trust

Yeovil, United Kingdom, BA21 4AT

Active, Not Recruiting

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Research Team

A

AURORA BIG HQ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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