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

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ClinicalTrials.gov Identifier: NCT02102165
Recruitment Status : Recruiting
First Posted : April 2, 2014
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Breast European Adjuvant Studies Team
Frontier Science & Technology Research Foundation, Inc.
Information provided by (Responsible Party):
Breast International Group

Tracking Information
First Submitted Date  ICMJE March 19, 2014
First Posted Date  ICMJE April 2, 2014
Last Update Posted Date March 22, 2018
Actual Study Start Date  ICMJE April 2014
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
Metastatic Breast Cancer (MBC) understanding [ Time Frame: 1 year after end of acrrual ]
To improve the understanding of MBC by performing high coverage Targeted Gene Sequencing (TGS) and RNA sequencing on matched primary and metastatic samples to explore tumor heterogeneity, clonal evolution and transcriptional changes associated with mutational and copy number variation (CNV) patterns.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • Building new therapeutic hypotheses [ Time Frame: 1 year after end of accrual and subsequently during follow up period of 10 years ]
    To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).
  • Patients' prognosis determination [ Time Frame: 1 year after end of accrual and subsequently during follow up period of 10 years ]
    To evaluate the prognostic relevance of genomic alterations detected in tumor metastatic biopsies and archived primary tissue
  • Identification of "exceptional responders" and "rapid progressors"; the outlier patients [ Time Frame: 1 year after end of accrual and subsequently during follow up period of 10 years ]
    To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomics data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol)
  • Feasibility of implementing a global molecular screening platform for MBC [ Time Frame: 1 year after end of accrual ]
    To provide evidence that can contribute in assessing the feasibility of implementing a global molecular screening platform of MBC
  • Correlation between molecular alterations and standardly assessed efficacy endpoints [ Time Frame: 1 year after end of accrual and subsequently during follow up period of 10 years ]
    To correlate molecular alterations in patients with the efficacy endpoints (response rate, progression-free survival and overall survival) set forth in clinical study protocols.
  • Patient identification to match with biomarker-driven clinical trials [ Time Frame: on ongoing basis during 3 years' patient recruitment ]
    To identify patients with candidate driver alterations in their tumors that can be matched to biomarker-driven clinical trials.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
Official Title  ICMJE AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: metastatic lesion biopsy
biopsy of metastatic lesion will be performed at program inclusion or maximum 6 months prior to inclusion. Sample of primary tumor must be available at inclusion.
Intervention: Procedure: metastatic lesion biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2015)
1000
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2014)
1300
Estimated Study Completion Date  ICMJE January 2029
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women or men with metastatic or locally relapsed breast cancer manageable with systemic therapy
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  3. Written informed consent prior to enrollment into the program.
  4. Patient aged ≥ 18 years
  5. Patient agrees to provide archived primary tumor tissue
  6. Patient agrees to provide newly collected metastatic lesions tissue samples (archived material up to 6 months is allowed provided both Formalin Fixed Paraffin Embedded (FFPE) block and Frozen Tissue are available and were collected from the same lesion at the same time)
  7. Patient agrees to provide blood samples

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. Patients with bone-only metastatic disease
  4. Patients with brain-only metastatic disease, unless surgical excision is planned (in which case tissue will be collected for AURORA purpose)
  5. Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI)
  6. Platelet count<100 000/mm3, INR>1.5 (international normalized ratio; blood clotting time) , Albumin<30
  7. 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
  8. Any anti-VEGF (vascular endothelial growth factor) or anti-VEGFR (vascular endothelial growth factor receptor) treatment administered less than 4 weeks before new biopsy procedure or no appropriate wash-out period for patients on anticoagulation therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AURORA BIG HQ aurora.bighq@bigagainstbc.org
Listed Location Countries  ICMJE Belgium,   Germany,   Iceland,   Italy,   Luxembourg,   Poland,   Portugal,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02102165
Other Study ID Numbers  ICMJE BIG 14-01
1408-BCG ( Other Identifier: EORTC )
GBG 85 ( Other Identifier: German Breast Cancer Group (GBG) )
ICR-CTSU/2014/10050 ( Other Identifier: The Institute of Cancer Research, UK )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Breast International Group
Study Sponsor  ICMJE Breast International Group
Collaborators  ICMJE
  • Breast European Adjuvant Studies Team
  • Frontier Science & Technology Research Foundation, Inc.
Investigators  ICMJE
Principal Investigator: Philippe Aftimos, MD Institut Jules Bordet, Brussels, Belgium
Principal Investigator: Mafalda Oliveira, MD University Hospital Vall d'Hebron,Barcelona, Catalonia, Spain
PRS Account Breast International Group
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP