Metastatic Breast CancerAURORANCT02102165
AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
A study testing metastatic lesion biopsy in people with Metastatic Breast Cancer, run by Jules Bordet Institute at 52 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- metastatic lesion biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 52 sitesin 10 countries
- Study dates
- Apr 2014to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
- Patient agrees to provide blood samples at regular intervals, from the screening as well as during the follow-up phase of the program.
Who cannot join
- 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.
Trial locations and contacts
52 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
AURORA BIG HQ contact
52 sites in 10 countries
Spain15 sites, 4 recruiting
- Recruiting
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
- Recruiting
Hospital del Mar
Barcelona, 08003
- Active, not recruiting
Dr Rosell Oncology Institute, Quirón Dexeus University Hospital
Barcelona, 08028
- Active, not recruiting
Hospital Vall d'Hebron
Barcelona, 08035
- Active, not recruiting
Hospital San Pedro de Alcantara
Cáceres, 10003
- Completed
Consorcio Hospitalario Provincial de Castellón
Castellon, 12002
- Active, not recruiting
Hospital Universitari Arnau de Vilanova
Lleida, 25198
- Active, not recruiting
MD Anderson Cancer Center
Madrid, 28033
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Active, not recruiting
Centro Integral Oncológico Clara Campa
Madrid, 28050
- Completed
Hospital Universitario Virgen del Rocio
Seville, 41013
- Recruiting
Instituto Valenciano de Oncología
Valencia, 46009
- Active, not recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
- Completed
Hospital General Universitario de Valencia
Valencia, 46014
United Kingdom11 sites
- Active, not recruiting
Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
- Active, not recruiting
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8HW
- Active, not recruiting
Velindre NHS Trust
Cardiff, CF15 7QZ
- Active, not recruiting
NHS Tayside, Ninewells Hospital
Dundee, DD1 9SY
- Active, not recruiting
Edinburgh Cancer Centre - Western General Hospital
Edinburgh, EH4 2XU
- Active, not recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
- Active, not recruiting
Christie NHS Foundation Trust
Manchester
- Active, not recruiting
Nottingham University Hospital NHS Trust
Nottingham
- Active, not recruiting
Singleton Hospital - ABM University Health Board
Swansea, SA2 8QA
- Active, not recruiting
Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ
- Active, not recruiting
Yeovil District Hospital NHS Foundation Trust
Yeovil, BA21 4AT
Italy9 sites
- Completed
Ospedale degli Infermi - S.O.C.Oncologia
Biella
- Active, not recruiting
Ospedale di Bolzano - Oncologia Medica
Bolzano, 39100
- Active, not recruiting
Ospedale Ramazzini di Carpi
Carpi
- Active, not recruiting
IRCCS AOU San Martino-IST
Genova, 16132
- Active, not recruiting
ULSS 21 Legnago
Legnago, 37045
- Active, not recruiting
Istituto Europeo di Oncologia
Milan, 20141
- Active, not recruiting
UOC Oncologia Medica - AOU Parma
Parma, 43126
- Completed
Fondazione Salvatore Maugeri
Pavia
- Active, not recruiting
IRCCS Az Ospedaliera S.Maria Nuova
Reggio Emilia
Belgium6 sites, 5 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1000
- Recruiting
Cliniques Universitaires St-Luc
Brussels, 1200
- Recruiting
Grand Hopital Charleroi
Charleroi, 6000
- Recruiting
UZ Leuven
Leuven, 3000
- Active, not recruiting
CHU de Liège
Liège, 4000
- Recruiting
Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)
Namur, 5000
Switzerland4 sites
- Completed
Kantonsspital Baden
Baden
- Completed
Inselspital Bern
Bern
- Completed
Kantonsspital Graubuenden
Chur
- Completed
Luzerner Kantonsspital, Division of Medical Oncology
Lucerne, 6003
Germany2 sites
- Completed
Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum
Essen, 45136
- Active, not recruiting
Frauenkliniken Maistrasse-Innenstadt und Großhadern
München, 80336
Sweden2 sites
- Active, not recruiting
Sahlgrenska University Hospital
Gothenburg
- Active, not recruiting
Ryhov County Hospital
Jönköping, 55185
Portugal1 site, 1 recruiting
- Recruiting
Champalimaud Foundation
Lisbon, 1400-038
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- metastatic lesion biopsy
- Keywords
- Aurora, breast cancer, metastatic, molecular screening, targeted gene sequencing, molecular aberrations, exploratory, biomarker
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metastatic lesion biopsyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: metastatic lesion biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after end of acrrual
Secondary outcomes (6)
Identification of "exceptional responders" and "rapid progressors"; the outlier patients
To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomic data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol).
Measured: 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
Measured: 1 year after end of accrual
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.
Measured: on ongoing basis during 3 years' patient recruitment
Building new therapeutic hypotheses
To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).
Measured: 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 plasma ctDNA samples, tumor metastatic biopsies and archived primary tissue.
Measured: 1 year after end of accrual and subsequently during follow up period of 10 years
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).
Measured: 1 year after end of accrual and subsequently during follow up period of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2027 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Frontier Science & Technology Research Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Philippe Aftimos, MD, Principal investigator, Institut Jules Bordet, Brussels, BelgiumAngel Guerrero Zotano, MD, Principal investigator, Instituto Valenciano de Oncologia, Valencia, SpainMatteo Benelli, PhD, Principal investigator, Breast International Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102165
- Sponsor's protocol ID
- BIG 14-01
- Other IDs
- 1408-BCG, GBG 85, ICR-CTSU/2014/10050
- Acronym
- AURORA
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2014
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT02102165
- Acronym / sponsor ID
- AURORA / BIG 14-01
- Conditions
- Metastatic Breast Cancer
- Keywords
- Aurora, breast cancer, metastatic, molecular screening, targeted gene sequencing, molecular aberrations, exploratory, biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Frontier Science & Technology Research Foundation, Inc.
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic lesion biopsy | Experimental | Procedure: metastatic lesion biopsybiopsy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metastatic lesion biopsya 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 | Procedure or surgery | metastatic lesion biopsy |
Primary outcome
Metastatic Breast Cancer (MBC) understanding
Time frame: 1 year after end of acrrual
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.
6 secondary outcomes
Identification of "exceptional responders" and "rapid progressors"; the outlier patients
Time frame: 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
Time frame: 1 year after end of accrual
Patient identification to match with biomarker-driven clinical trials
Time frame: on ongoing basis during 3 years' patient recruitment
Building new therapeutic hypotheses
Time frame: 1 year after end of accrual and subsequently during follow up period of 10 years
Patients' prognosis determination
Time frame: 1 year after end of accrual and subsequently during follow up period of 10 years
Correlation between molecular alterations and standardly assessed efficacy endpoints
Time frame: 1 year after end of accrual and subsequently during follow up period of 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AURORA BIG HQ contact
Philippe Aftimos, MD principal investigator
Institut Jules Bordet, Brussels, Belgium
Angel Guerrero Zotano, MD principal investigator
Instituto Valenciano de Oncologia, Valencia, Spain
Matteo Benelli, PhD principal investigator
Breast International Group
52 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metastatic lesion biopsy in people with Metastatic Breast Cancer, run by Jules Bordet Institute at 52 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Spain, United Kingdom, Italy, Belgium, Switzerland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AURORA BIG HQ (aurora.bighq@bigagainstbc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastatic Breast Cancer (MBC) understanding (time frame: 1 year after end of acrrual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.