Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Follow-up | Other | — | UNRESOLVED |
| FoundationOne Dx Genomic Profile (archival Tumour Specimen) | Genetic | — | UNRESOLVED |
| Germline BRCA Test (blood) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observation
- description
- 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.
- interventionNames
- Genetic: Germline BRCA Test (blood)
- Genetic: FoundationOne Dx Genomic Profile (archival Tumour Specimen)
- Other: Follow-up
Primary outcomes (1)
- measure
- BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
- timeFrame
- At one time point at inclusion in the study up to 12 months after the beginning of the study.
- description
- 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).
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDKoh SJ, Ohsumi S, Takahashi M, Fukuma E, Jung KH, Ishida T, Dai MS, Chang CH, Dalvi T, Walker G, Bennett J, O'Shaughnessy J, Balmana J. Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study. Breast Cancer. 2022 Jan;29(1):92-102. doi: 10.1007/s12282-021-01283-4. Epub 2021 Aug 31. PMID 34467476
- DERIVEDO'Shaughnessy J, Brezden-Masley C, Cazzaniga M, Dalvi T, Walker G, Bennett J, Ohsumi S. Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study. Breast Cancer Res. 2020 Oct 27;22(1):114. doi: 10.1186/s13058-020-01349-9. PMID 33109210