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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03078036 |
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Date of registration:
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10/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
BREAKOUT |
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Scientific title:
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BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study |
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Date of first enrolment:
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March 13, 2017 |
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Target sample size:
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873 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03078036 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Australia
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Bulgaria
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Canada
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China
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France
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Germany
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Hungary
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Italy
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Japan
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Korea, Republic of
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Poland
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Russian Federation
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Spain
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Sweden
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Taiwan
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Turkey
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Provision of signed, written and dated informed consent.
2. Adult females (according to the age of majority/adulthood as defined by local
regulations).
3. Histologically or cytologically confirmed HER2-ve breast cancer with evidence of
metastatic disease.
4. Initiated treatment with 1st line systemic cytotoxic chemotherapy (not hormonal
therapy) for metastatic breast cancer in the last 90 days and, at that time, are
considered to have exhausted hormone therapy options (if HR+ve).
Exclusion Criteria:
1. Previous enrolment in this study.
2. Involvement in the planning and/or conduct of this study (applies to both AstraZeneca
staff and/or staff at the study site).
3. Current participation in a clinical study with an investigational oncology product.
4. Previous PARPi therapy, including, but not limited to, participation in a previous
clinical study that included PARPi therapy.
5. Current commencement of PARPi treatment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Genetic: Germline BRCA Test (blood)
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Other: Follow-up
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Genetic: FoundationOne Dx Genomic Profile (archival Tumour Specimen)
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Primary Outcome(s)
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BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
[Time Frame: At one time point at inclusion in the study up to 12 months after the beginning of the study.]
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Secondary Outcome(s)
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Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
[Time Frame: 2.5 years (30 months) since the beginning of the study.]
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Progression free survival by line of therapy
[Time Frame: 2.5 years (30 months) since the beginning of the study.]
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Overall survival by line of therapy
[Time Frame: 2.5 years (30 months) since the beginning of the study.]
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Secondary ID(s)
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D0816R00012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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