International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03078036

Run by

AstraZeneca

People needed

873

Starts

2017-03-13

Expected to finish

2019-05-20

Last updated by the study team

2020-05-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed, written and dated informed consent.
• Adult females (according to the age of majority/adulthood as defined by local regulations).
• Histologically or cytologically confirmed HER2-ve breast cancer with evidence of metastatic disease.
• 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).

You may not qualify if…

• Previous enrolment in this study.
• Involvement in the planning and/or conduct of this study (applies to both AstraZeneca staff and/or staff at the study site).
• Current participation in a clinical study with an investigational oncology product.
• Previous PARPi therapy, including, but not limited to, participation in a previous clinical study that included PARPi therapy.
• Current commencement of PARPi treatment.

Where it is running

• Research Site — Denver, Colorado, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Dallas, Texas, United States
• Research Site — Denton, Texas, United States
• Research Site — Flower Mound, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Paris, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — The Woodlands, Texas, United States
• Research Site — Newport News, Virginia, United States
• Research Site — Vancouver, Washington, United States
• Research Site — Wenatchee, Washington, United States
• Research Site — Redcliffe, Queensland, Australia
• Research Site — Kurralta Park, South Australia, Australia
• Research Site — Ballarat, Victoria, Australia
• Research Site — Dobrich, Bulgaria
• Research Site — Rousse, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Kingston, Ontario, Canada
• Research Site — Kitchener, Ontario, Canada
• Research Site — Chicoutimi, Quebec, Canada
• Research Site — Québec, Canada
• Research Site — Tübingen, Germany
• Research Site — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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