International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study - BREAKOUT
Study identifier:D0816R00012
ClinicalTrials.gov identifier:NCT03078036
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
Medical condition
Breast Cancer
Phase
N/A
Healthy volunteers
No
Study drug
-
Sex
Female
Actual Enrollment
873
Study type
Observational
Age
18 Years +
Date
Study Start Date: 13 Mar 2017
Primary Completion Date: 20 May 2019
Study Completion Date: 20 May 2019
Study design
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 May 2020 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Quintiles; University of Tubingen - Germany
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Observation Human epidermal growth factor receptor 2 negative metastic breast cancer patients who have started 1st line systemic cytotoxic chemotheraphy and are considered to have exhausted hormone therapy options (if HR+ve), per investigator’s opinion. | Genetic: Germline BRCA Test (blood) If unavailable from the patient medical records, gBRCA gene mutation status will be tested as aligned to local clinical practice using a blood sample obtained preferably during routine clinical practice. (Note: Blood samples may be shipped to a central laboratory for testing and storage, based on local regulations for shipment of blood samples.) Genetic: FoundationOne Dx Genomic Profile (archival Tumour Specimen) Archival tumour specimen will be requested from all patients in the informed consent, but is not required for study enrolment (optional consent). Where sufficient archival tumour specimen is available and patients have consented to tumour specimen testing, FoundationOne Dx genomic profiling may take place as follows: - Tumour Specimen: Acceptable samples include formalin-fixed, paraffin embedded (FFPE) tissue (preferred) or FFPE specimens, including core needle biopsies, fine-needle aspirates and effusion cytologies. - Tumour Testing (optional): archival tumour specimens, where available, will be tested for mutations in HRR genes including BRCA1 and BRCA2 and other genomic alterations using the FoundationOne Dx genomic profile. Other: Follow-up Patients who test positive for a gBRCA gene mutation, and/or sBRCA or other HRR gene mutations (optional testing), will be followed prospectively for assessment of treatment patterns and associated clinical outcomes up to 30-months. - Patients who test negative for gBRCA gene mutations, sBRCA and other HRR gene mutations, no further data will be collected post baseline. Patients presenting other genomic alterations that are identified by the FoundationOne Dx genomic profile will not continue beyond baseline as part of this study. |
