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Can mapping tumor DNA unlock personalized breast cancer care?

NCT ID NCT02102165

Knowledge-focused Sponsor: Jules Bordet Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

The AURORA study is collecting tumor and blood samples from 1,300 people with metastatic breast cancer across Europe. By analyzing genetic changes in both the original and metastatic tumors, researchers hope to understand why some patients respond well to therapy while others do not. The goal is to identify the right treatment for each individual and ultimately improve outcomes for all patients with this advanced disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
metastatic lesion biopsy
What this could lead to
If successful, this could lead to more personalized treatments for metastatic breast cancer, improving outcomes for patients.
What could go wrong
This is an observational study, so it won't directly test a treatment. The findings may not immediately translate into new therapies, and the genetic complexity of the disease may limit generalizable conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2014

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive lobular breast carcinoma Neoplasm Metastasis triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beatson West of Scotland Cancer Centre

    ACTIVE_NOT_RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • CHU de Liège

    ACTIVE_NOT_RECRUITING

    Liège, 4000, Belgium

  • Centre Hospitalier

    ACTIVE_NOT_RECRUITING

    Luxembourg, 1210, Luxembourg

  • Centro Integral Oncológico Clara Campa

    ACTIVE_NOT_RECRUITING

    Madrid, 28050, Spain

  • Champalimaud Foundation

    RECRUITING

    Lisbon, 1400-038, Portugal

  • Christie NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Manchester, United Kingdom

  • Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)

    RECRUITING

    Namur, 5000, Belgium

  • Cliniques Universitaires St-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Complexo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Consorcio Hospitalario Provincial de Castellón

    COMPLETED

    Castellon, 12002, Spain

  • Dr Rosell Oncology Institute, Quirón Dexeus University Hospital

    ACTIVE_NOT_RECRUITING

    Barcelona, 08028, Spain

  • Edinburgh Cancer Centre - Western General Hospital

    ACTIVE_NOT_RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Fondazione Salvatore Maugeri

    COMPLETED

    Pavia, Italy

  • Frauenkliniken Maistrasse-Innenstadt und Großhadern

    ACTIVE_NOT_RECRUITING

    München, 80336, Germany

  • Grand Hopital Charleroi

    RECRUITING

    Charleroi, 6000, Belgium

  • Hospital Clinico Universitario de Valencia

    ACTIVE_NOT_RECRUITING

    Valencia, 46010, Spain

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital General Universitario de Valencia

    COMPLETED

    Valencia, 46014, Spain

  • Hospital San Pedro de Alcantara

    ACTIVE_NOT_RECRUITING

    Cáceres, 10003, Spain

  • Hospital Universitari Arnau de Vilanova

    ACTIVE_NOT_RECRUITING

    Lleida, 25198, Spain

  • Hospital Universitario 12 de Octubre

    ACTIVE_NOT_RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen del Rocio

    COMPLETED

    Seville, 41013, Spain

  • Hospital Vall d'Hebron

    ACTIVE_NOT_RECRUITING

    Barcelona, 08035, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • IRCCS AOU San Martino-IST

    ACTIVE_NOT_RECRUITING

    Genova, 16132, Italy

  • IRCCS Az Ospedaliera S.Maria Nuova

    ACTIVE_NOT_RECRUITING

    Reggio Emilia, Italy

  • Inselspital Bern

    COMPLETED

    Bern, Switzerland

  • Institut Jules Bordet

    RECRUITING

    Brussels, 1000, Belgium

  • Instituto Valenciano de Oncología

    RECRUITING

    Valencia, 46009, Spain

  • Istituto Europeo di Oncologia

    ACTIVE_NOT_RECRUITING

    Milan, 20141, Italy

  • Kantonsspital Baden

    COMPLETED

    Baden, Switzerland

  • Kantonsspital Graubuenden

    COMPLETED

    Chur, Switzerland

  • Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum

    COMPLETED

    Essen, 45136, Germany

  • Landspitali

    ACTIVE_NOT_RECRUITING

    Reykjavik, 101, Iceland

  • Luzerner Kantonsspital, Division of Medical Oncology

    COMPLETED

    Lucerne, 6003, Switzerland

  • MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Madrid, 28033, Spain

  • NHS Tayside, Ninewells Hospital

    ACTIVE_NOT_RECRUITING

    Dundee, DD1 9SY, United Kingdom

  • Nottingham University Hospital NHS Trust

    ACTIVE_NOT_RECRUITING

    Nottingham, United Kingdom

  • Ospedale Ramazzini di Carpi

    ACTIVE_NOT_RECRUITING

    Carpi, Italy

  • Ospedale degli Infermi - S.O.C.Oncologia

    COMPLETED

    Biella, Italy

  • Ospedale di Bolzano - Oncologia Medica

    ACTIVE_NOT_RECRUITING

    Bolzano, 39100, Italy

  • Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust

    ACTIVE_NOT_RECRUITING

    Truro, TR1 3LJ, United Kingdom

  • Ryhov County Hospital

    ACTIVE_NOT_RECRUITING

    Jönköping, 55185, Sweden

  • Sahlgrenska University Hospital

    ACTIVE_NOT_RECRUITING

    Gothenburg, Sweden

  • Singleton Hospital - ABM University Health Board

    ACTIVE_NOT_RECRUITING

    Swansea, SA2 8QA, United Kingdom

  • ULSS 21 Legnago

    ACTIVE_NOT_RECRUITING

    Legnago, 37045, Italy

  • UOC Oncologia Medica - AOU Parma

    ACTIVE_NOT_RECRUITING

    Parma, 43126, Italy

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Hospitals Bristol NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Bristol, BS2 8HW, United Kingdom

  • Velindre NHS Trust

    ACTIVE_NOT_RECRUITING

    Cardiff, CF15 7QZ, United Kingdom

  • Yeovil District Hospital NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Yeovil, BA21 4AT, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.