Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02102165
Other study ID # BIG 14-01
Secondary ID 1408-BCGGBG 85IC
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date March 2031

Study information

Verified date April 2024
Source Breast International Group
Contact AURORA BIG HQ
Email aurora.bighq@bigagainstbc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date March 2031
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Belgium Cliniques Universitaires St-Luc Brussels
Belgium Institut Jules Bordet Brussels
Belgium Grand Hopital Charleroi Charleroi
Belgium UZ Leuven Leuven
Belgium CHU de Liège Liège
Belgium Clinique et Maternité Sainte-Elisabeth (CMSE - Namur) Namur
Germany Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum Essen
Germany Frauenkliniken Maistrasse-Innenstadt und Großhadern München
Iceland Landspitali Reykjavík
Italy Ospedale degli Infermi - S.O.C.Oncologia Biella
Italy Ospedale di Bolzano - Oncologia Medica Bolzano
Italy Ospedale Ramazzini di Carpi Carpi
Italy IRCCS AOU San Martino-IST Genova
Italy ULSS 21 Legnago Legnago
Italy Istituto Europeo di Oncologia Milano
Italy UOC Oncologia Medica - AOU Parma Parma
Italy Fondazione Salvatore Maugeri Pavia
Italy IRCCS Az Ospedaliera S.Maria Nuova Reggio Emilia
Luxembourg Centre Hospitalier Luxembourg
Portugal Champalimaud Foundation Lisboa
Spain Complexo Hospitalario Universitario A Coruña A Coruña
Spain Dr Rosell Oncology Institute, Quirón Dexeus University Hospital Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital San Pedro de Alcantara Cáceres
Spain Consorcio Hospitalario Provincial de Castellón Castellón De La Plana
Spain Hospital Universitari Arnau de Vilanova Lleida
Spain Centro Integral Oncológico Clara Campa Madrid
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain MD Anderson Cancer Center Madrid
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital General Universitario de Valencia Valencia
Spain Instituto Valenciano de Oncología Valencia
Sweden Sahlgrenska University Hospital Gothenburg
Sweden Ryhov County Hospital Jönköping
Switzerland Kantonsspital Baden Baden
Switzerland Inselspital Bern Bern
Switzerland Kantonsspital Graubuenden Chur
Switzerland Luzerner Kantonsspital, Division of Medical Oncology Lucerne
United Kingdom Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust Birmingham
United Kingdom University Hospitals Bristol NHS Foundation Trust Bristol
United Kingdom Velindre NHS Trust Cardiff
United Kingdom NHS Tayside, Ninewells Hospital Dundee
United Kingdom Edinburgh Cancer Centre - Western General Hospital Edinburgh
United Kingdom Beatson West of Scotland Cancer Centre Glasgow
United Kingdom Christie NHS Foundation Trust Manchester
United Kingdom Nottingham University Hospital NHS Trust Nottingham
United Kingdom Singleton Hospital - ABM University Health Board Swansea
United Kingdom Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust Truro
United Kingdom Yeovil District Hospital NHS Foundation Trust Yeovil

Sponsors (3)

Lead Sponsor Collaborator
Breast International Group Frontier Science & Technology Research Foundation, Inc., Jules Bordet Institute

Countries where clinical trial is conducted

Belgium,  Germany,  Iceland,  Italy,  Luxembourg,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metastatic Breast Cancer (MBC) understanding To improve the understanding of locally recurrent/advanced BC and MBC by using high-throughput technologies on primary, metastatic, as well as plasma ctDNA samples, to explore tumor heterogeneity, clonal evolution and transcriptional changes associated with mutational and copy number variation (CNV) patterns. 1 year after end of acrrual
Secondary Identification of "exceptional responders" and "rapid progressors"; the outlier patients To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomic data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol). 1 year after end of accrual and subsequently during follow up period of 10 years
Secondary Feasibility of implementing a global molecular screening platform for MBC To provide evidence that can contribute in assessing the feasibility of implementing a global molecular screening platform of MBC 1 year after end of accrual
Secondary Patient identification to match with biomarker-driven clinical trials To identify patients with candidate driver alterations in their tumors that can be matched to biomarker-driven clinical trials. on ongoing basis during 3 years' patient recruitment
Secondary Building new therapeutic hypotheses To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS). 1 year after end of accrual and subsequently during follow up period of 10 years
Secondary Patients' prognosis determination To evaluate the prognostic relevance of genomic alterations detected in plasma ctDNA samples, tumor metastatic biopsies and archived primary tissue. 1 year after end of accrual and subsequently during follow up period of 10 years
Secondary Correlation between molecular alterations and standardly assessed efficacy endpoints To correlate molecular alterations in patients with the efficacy endpoints (response rate, progression-free survival and overall survival). 1 year after end of accrual and subsequently during follow up period of 10 years
See also
  Status Clinical Trial Phase
Withdrawn NCT04872608 - A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer Phase 1
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Completed NCT02506556 - Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer Phase 2
Recruiting NCT05534438 - A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer Phase 2
Recruiting NCT03368729 - Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Completed NCT04103853 - Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer Phase 1
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Active, not recruiting NCT03147287 - Palbociclib After CDK and Endocrine Therapy (PACE) Phase 2
Not yet recruiting NCT06062498 - Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Active, not recruiting NCT04432454 - Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Phase 2
Recruiting NCT03323346 - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer Phase 2
Recruiting NCT05744375 - Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab Phase 2
Completed NCT02924883 - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy Phase 2
Completed NCT01942135 - Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Phase 3
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
Completed NCT01401959 - Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy Phase 2
Terminated NCT04720664 - Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer Phase 2

External Links