International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
Public ClinicalTrials.gov record NCT03078036. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03078036
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 873 participants
Conditions and interventions
Conditions
Interventions
- Germline BRCA Test (blood) Genetic
- FoundationOne Dx Genomic Profile (archival Tumour Specimen) Genetic
- Follow-up Other
Genetic · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 13, 2017 (Actual)
- Primary completion
- May 20, 2019 (Actual)
- Completion
- May 20, 2019 (Actual)
- Last update posted
- May 20, 2020
2017 – 2019
United States locations
- U.S. sites
- 14
- U.S. states
- 6
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Santa Barbara | California | 93105 | — |
| Research Site | Denver | Colorado | 80218 | — |
| Research Site | Hialeah | Florida | 33012 | — |
| Research Site | Dallas | Texas | 75246 | — |
| Research Site | Denton | Texas | 76210 | — |
| Research Site | Flower Mound | Texas | 75028 | — |
| Research Site | Houston | Texas | 77024 | — |
| Research Site | Houston | Texas | 77089 | — |
| Research Site | Paris | Texas | 75460 | — |
| Research Site | San Antonio | Texas | 78217 | — |
| Research Site | The Woodlands | Texas | 77380 | — |
| Research Site | Newport News | Virginia | 23601 | — |
| Research Site | Vancouver | Washington | 98684 | — |
| Research Site | Wenatchee | Washington | 98801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 84 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03078036, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03078036 live on ClinicalTrials.gov.