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Clinical Trials in Germany / NCT02102165
Recruiting Not applicable

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

NCT02102165 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2014-04
Last updated
2026-08-06

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

metastatic lesion biopsy

metastatic lesion biopsy: 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 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Institut Jules Bordet Brussels Belgium Recruiting
Cliniques Universitaires St-Luc Brussels Belgium Recruiting
Grand Hopital Charleroi Charleroi Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
CHU de Liège Liège Belgium Active Not Recruiting
Clinique et Maternité Sainte-Elisabeth (CMSE - Namur) Namur Belgium Recruiting
Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum Essen Germany Completed
Frauenkliniken Maistrasse-Innenstadt und Großhadern München Germany Active Not Recruiting
Landspitali Reykjavik Iceland Active Not Recruiting
Ospedale degli Infermi - S.O.C.Oncologia Biella Italy Completed
Ospedale di Bolzano - Oncologia Medica Bolzano Italy Active Not Recruiting
Ospedale Ramazzini di Carpi Carpi Italy Active Not Recruiting
IRCCS AOU San Martino-IST Genova Italy Active Not Recruiting
ULSS 21 Legnago Legnago Italy Active Not Recruiting
Istituto Europeo di Oncologia Milan Italy Active Not Recruiting
UOC Oncologia Medica - AOU Parma Parma Italy Active Not Recruiting
Fondazione Salvatore Maugeri Pavia Italy Completed
IRCCS Az Ospedaliera S.Maria Nuova Reggio Emilia Italy Active Not Recruiting
Centre Hospitalier Luxembourg Luxembourg Active Not Recruiting
Champalimaud Foundation Lisbon Portugal Recruiting
Complexo Hospitalario Universitario A Coruña A Coruña Spain Recruiting
Hospital del Mar Barcelona Spain Recruiting
Dr Rosell Oncology Institute, Quirón Dexeus University Hospital Barcelona Spain Active Not Recruiting
Hospital Vall d'Hebron Barcelona Spain Active Not Recruiting
Consorcio Hospitalario Provincial de Castellón Castellon Spain Completed
Hospital San Pedro de Alcantara Cáceres Spain Active Not Recruiting
Hospital Universitari Arnau de Vilanova Lleida Spain Active Not Recruiting
MD Anderson Cancer Center Madrid Spain Active Not Recruiting
Hospital Clínico San Carlos Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Active Not Recruiting
Centro Integral Oncológico Clara Campa Madrid Spain Active Not Recruiting
Hospital Universitario Virgen del Rocio Seville Spain Completed
Instituto Valenciano de Oncología Valencia Spain Recruiting
Hospital Clinico Universitario de Valencia Valencia Spain Active Not Recruiting
Hospital General Universitario de Valencia Valencia Spain Completed
Sahlgrenska University Hospital Gothenburg Sweden Active Not Recruiting
Ryhov County Hospital Jönköping Sweden Active Not Recruiting
Kantonsspital Baden Baden Switzerland Completed
Inselspital Bern Bern Switzerland Completed
Kantonsspital Graubuenden Chur Switzerland Completed

+ 12 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02102165 on ClinicalTrials.gov ↗ ← All trials in Germany