AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
Recruiting · NCT02102165 · Interventional (participants receive a specific treatment) · Lead sponsor: Jules Bordet Institute
View the official record on ClinicalTrials.gov →Interventions studied
metastatic lesion biopsy
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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.
Where it is running
52 locations listed.
- Complexo Hospitalario Universitario A Coruña - A Coruña, Spain
- Kantonsspital Baden - Baden, Switzerland
- Hospital del Mar - Barcelona, Spain
- Dr Rosell Oncology Institute, Quirón Dexeus University Hospital - Barcelona, Spain
- Hospital Vall d'Hebron - Barcelona, Spain
- Inselspital Bern - Bern, Switzerland
- Ospedale degli Infermi - S.O.C.Oncologia - Biella, Italy
- Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust - Birmingham, United Kingdom
- Ospedale di Bolzano - Oncologia Medica - Bolzano, Italy
- University Hospitals Bristol NHS Foundation Trust - Bristol, United Kingdom
- Institut Jules Bordet - Brussels, Belgium
- Cliniques Universitaires St-Luc - Brussels, Belgium
- Velindre NHS Trust - Cardiff, United Kingdom
- Ospedale Ramazzini di Carpi - Carpi, Italy
- Consorcio Hospitalario Provincial de Castellón - Castellon, Spain
- Grand Hopital Charleroi - Charleroi, Belgium
- Kantonsspital Graubuenden - Chur, Switzerland
- Hospital San Pedro de Alcantara - Cáceres, Spain
- NHS Tayside, Ninewells Hospital - Dundee, United Kingdom
- Edinburgh Cancer Centre - Western General Hospital - Edinburgh, United Kingdom
- Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum - Essen, Germany
- IRCCS AOU San Martino-IST - Genova, Italy
- Beatson West of Scotland Cancer Centre - Glasgow, United Kingdom
- Sahlgrenska University Hospital - Gothenburg, Sweden
- Ryhov County Hospital - Jönköping, Sweden
- ULSS 21 Legnago - Legnago, Italy
- UZ Leuven - Leuven, Belgium
- Champalimaud Foundation - Lisbon, Portugal
- CHU de Liège - Liège, Belgium
- Hospital Universitari Arnau de Vilanova - Lleida, Spain
- Luzerner Kantonsspital, Division of Medical Oncology - Lucerne, Switzerland
- Centre Hospitalier - Luxembourg, Luxembourg
- MD Anderson Cancer Center - Madrid, Spain
- Hospital Clínico San Carlos - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Centro Integral Oncológico Clara Campa - Madrid, Spain
- Christie NHS Foundation Trust - Manchester, United Kingdom
- Istituto Europeo di Oncologia - Milan, Italy
- Frauenkliniken Maistrasse-Innenstadt und Großhadern - München, Germany
- Clinique et Maternité Sainte-Elisabeth (CMSE - Namur) - Namur, Belgium
- Nottingham University Hospital NHS Trust - Nottingham, United Kingdom
- UOC Oncologia Medica - AOU Parma - Parma, Italy
- Fondazione Salvatore Maugeri - Pavia, Italy
- IRCCS Az Ospedaliera S.Maria Nuova - Reggio Emilia, Italy
- Landspitali - Reykjavik, Iceland
- Hospital Universitario Virgen del Rocio - Seville, Spain
- Singleton Hospital - ABM University Health Board - Swansea, United Kingdom
- Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust - Truro, United Kingdom
- Instituto Valenciano de Oncología - Valencia, Spain
- Hospital Clinico Universitario de Valencia - Valencia, Spain
- Hospital General Universitario de Valencia - Valencia, Spain
- Yeovil District Hospital NHS Foundation Trust - Yeovil, United Kingdom