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NCT03078036 · ClinicalTrials.gov registry record
International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
A clinical trial of Breast Cancer, sponsored by AstraZeneca.
- Completed
- Registry status
- 873
- Enrollment target
- 20
- Study locations
NCT03078036: Completed study of Breast Cancer, sponsored by AstraZeneca.
NCT03078036 is a study of Breast Cancer that has completed, run by AstraZeneca. The registered enrollment target is 873 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078036, a study of Breast Cancer, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 873 participants
- Enrollment target
- 20
- Study locations
Study Summary
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.
Primary Outcome
The prevalence of gBRCA gene mutations will be evaluated by calculating the proportion of patients that test positive for a gBRCA gene mutation (BRCA1 mutated and/or BRCA2 mutated).
Conditions Studied
Interventions
- GENETIC Germline BRCA Test (blood)
- GENETIC FoundationOne Dx Genomic Profile (archival Tumour Specimen)
- OTHER Follow-up
Study Locations (20)
Texas
- Research Site - Dallas
- Research Site - Denton
- Research Site - Flower Mound
- Research Site - Houston
- Research Site - Houston
- Research Site - Paris
- Research Site - San Antonio
- Research Site - The Woodlands
Other
- Research Site - Dobrich
- Research Site - Rousse
- Research Site - Sofia
Washington
- Research Site - Vancouver
- Research Site - Wenatchee
California
- Research Site - Santa Barbara
Colorado
- Research Site - Denver
Florida
- Research Site - Hialeah
Virginia
- Research Site - Newport News
Queensland
- Research Site - Redcliffe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 873 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2019-05-20 |
What the finished NCT03078036 record still lists
NCT03078036 is an observational study that tracks outcomes without assigning an intervention. The registered 873 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Germline BRCA Test (blood) is the first listed.
NCT03078036 names 20 study sites across 10 states, led by Texas, Other, Washington.
Frequently Asked Questions
What is clinical trial NCT03078036 about?
NCT03078036 is a clinical study titled "International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study". BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The...
What is the current status of trial NCT03078036?
This trial is currently completed. The enrollment target is 873 participants. The study started on 2017-03-13. Estimated completion is 2019-05-20.
What conditions does trial NCT03078036 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03078036?
The interventions under investigation include: Germline BRCA Test (blood) (GENETIC), FoundationOne Dx Genomic Profile (archival Tumour Specimen) (GENETIC), Follow-up (OTHER).
Who is sponsoring clinical trial NCT03078036?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03078036 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03078036's enrollment target sits among peer trials
873 139th of 1224 higher than 1,086 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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