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

Sponsor: Jules Bordet Institute

NCT ID: NCT02102165

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
metastatic lesion biopsy (procedure)
How long the study runs
Study runs about 203 months (dates as stated)
About the drug or intervention
metastatic lesion biopsy — procedure: 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
Patient visit burden
Not specified by the sponsor

In plain English

AURORA is a research programme run by the Jules Bordet Institute for people with metastatic breast cancer (breast cancer that has spread) or breast cancer that has come back locally and cannot be cured. It aims to understand the molecular changes (changes in the cancer's genes and proteins) in these cancers by studying tumour tissue and blood samples over time.

Who can take part

  • Adults aged 18 or over, female or male, with breast cancer that has spread or come back and cannot be treated with the aim of cure, who have had no more than one course of systemic treatment (treatment that travels through the body) for the spread cancer.
  • Under protocol version 4.0, only certain groups can join: triple-negative breast cancer, invasive lobular breast cancer, or breast cancer that came back more than 10 years after the first diagnosis.
  • Being well enough for everyday activity (performance status 0 or 1).
  • Having tissue from the original tumour available for research.
  • Having a metastatic tumour site (where the cancer has spread) that can be biopsied (a small sample taken), and agreeing to that biopsy. Biopsies from bone are accepted if the site has not had radiotherapy before. Brain tissue is accepted only if removed during routine surgery not planned for this study.
  • The biopsy must be done either before starting the first treatment for the relapsed cancer, or when the cancer first gets worse before starting a second treatment.
  • Having blood, serum and plasma samples taken at screening, and agreeing to give blood samples at regular intervals during follow-up.
  • Giving written informed consent (signed agreement) before joining.

Who may not be able to

  • Having had more than one course of systemic treatment in the metastatic setting.
  • Having had palliative radiotherapy (radiotherapy to ease symptoms) to the only place that can be biopsied.
  • Severe problems with blood-making, kidney or liver function, including low albumin (a blood protein).
  • Known higher risk of serious bleeding during the biopsy, as judged by your doctor.
  • Another cancer in the last 5 years, except fully treated cervical cancer in situ and treated skin cancers (basal cell or squamous cell).

What taking part involves

  • • A biopsy (small tissue sample) of a metastatic tumour, done at set time points.
  • • Providing tissue from your original tumour for research.
  • • Blood, serum and plasma samples taken at screening and at regular intervals during follow-up.
  • • Not stated — ask the trial team (whether any specific treatment is given as part of this programme).

Time commitment: Taking part involves a tumour biopsy, giving blood samples at screening and at regular follow-up visits; total duration not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2014-04
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic breast cancer
  • • NA - 1,000 participants
  • • This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic breast cancer

Where?

  • • Birmingham - Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
  • • Bristol - University Hospitals Bristol NHS Foundation Trust
  • • Cardiff - Velindre NHS Trust
  • • Dundee - NHS Tayside, Ninewells Hospital
  • • +7 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Metastatic Breast Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

ERHER2HER2 negativemorphology or negativemet

Treatment history

Treatments you must have had:

  • ✓ a metastatic lesion accessible for biopsy and must agree with the biopsy procedure

What the study is looking for

  • ✓Under protocol 4.0, eligible patients will be limited to locally recurrent/advanced breast cancer not amenable to...
  • ✓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...
  • ✓late relapse BC (any subtype). Late relapse is defined as a patient with a radiologic or histologic confirmation of...
  • ✓Written agreement to take part prior to registration into the program.

Who cannot take part

  • ✗The patient has received more than 1 line of treatment that goes through your whole body (any type) in the that has spread setting.
  • ✗Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy.
  • ✗Presence of severe hematopoietic, kidney, and/or liver dysfunction, including but not restricted to albumin \< 3 g/dl.
  • ✗Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.
See the full 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.

Where Is This Study? (11 UK sites)

Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2TH, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

University Hospitals Bristol NHS Foundation Trust

Bristol BS2 8HW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Diana Benton

research@uhbw.nhs.uk0117 342 0233

Velindre NHS Trust

Cardiff CF15 7QZ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

NHS Tayside, Ninewells Hospital

Dundee DD1 9SY, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Mrs Liz Coote

Liz.Coote@nhs.scot01382 383876

Edinburgh Cancer Centre - Western General Hospital

Edinburgh EH4 2XU, United Kingdom

ACTIVE_NOT_RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Christie NHS Foundation Trust

Manchester, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Singleton Hospital - ABM University Health Board

Swansea SA2 8QA, United Kingdom

ACTIVE_NOT_RECRUITING

Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust

Truro TR1 3LJ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

Yeovil District Hospital NHS Foundation Trust

Yeovil BA21 4AT, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

AURORA BIG HQ

Sponsor contact

CONTACT

aurora.bighq@bigagainstbc.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-07