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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (11 UK sites)
Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
Birmingham B15 2TH, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol BS2 8HW, United Kingdom
Velindre NHS Trust
Cardiff CF15 7QZ, United Kingdom
NHS Tayside, Ninewells Hospital
Dundee DD1 9SY, United Kingdom
Edinburgh Cancer Centre - Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom
Singleton Hospital - ABM University Health Board
Swansea SA2 8QA, United Kingdom
Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
Truro TR1 3LJ, United Kingdom
Yeovil District Hospital NHS Foundation Trust
Yeovil BA21 4AT, United Kingdom
How to Get in Touch
AURORA BIG HQ
Sponsor contactCONTACT
