International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
BREAKOUT
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
1 other identifier
observational
873
15 countries
98
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
March 13, 2017
CompletedStudy Start
First participant enrolled
March 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2019
CompletedMay 20, 2020
May 1, 2020
2.2 years
February 10, 2017
May 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
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).
At one time point at inclusion in the study up to 12 months after the beginning of the study.
Secondary Outcomes (3)
Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
2.5 years (30 months) since the beginning of the study.
Progression free survival by line of therapy
2.5 years (30 months) since the beginning of the study.
Overall survival by line of therapy
2.5 years (30 months) since the beginning of the study.
Study Arms (1)
Observation
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.
Interventions
If unavailable from the patient medical records, gBRCA gene mutation status will be tested as aligned to local clinical practice using a blood sample obtained preferably during routine clinical practice. (Note: Blood samples may be shipped to a central laboratory for testing and storage, based on local regulations for shipment of blood samples.)
Archival tumour specimen will be requested from all patients in the informed consent, but is not required for study enrolment (optional consent). Where sufficient archival tumour specimen is available and patients have consented to tumour specimen testing, FoundationOne Dx genomic profiling may take place as follows: * Tumour Specimen: Acceptable samples include formalin-fixed, paraffin embedded (FFPE) tissue (preferred) or FFPE specimens, including core needle biopsies, fine-needle aspirates and effusion cytologies. * Tumour Testing (optional): archival tumour specimens, where available, will be tested for mutations in HRR genes including BRCA1 and BRCA2 and other genomic alterations using the FoundationOne Dx genomic profile.
Patients who test positive for a gBRCA gene mutation, and/or sBRCA or other HRR gene mutations (optional testing), will be followed prospectively for assessment of treatment patterns and associated clinical outcomes up to 30-months. \- Patients who test negative for gBRCA gene mutations, sBRCA and other HRR gene mutations, no further data will be collected post baseline. Patients presenting other genomic alterations that are identified by the FoundationOne Dx genomic profile will not continue beyond baseline as part of this study.
Eligibility Criteria
Centers for primary care of metastatic HER2-ve breast cancer patients
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Quintiles; University of Tubingen - Germanycollaborator
Study Sites (98)
Research Site
Santa Barbara, California, 93105, United States
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Denver, Colorado, 80218, United States
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Hialeah, Florida, 33012, United States
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Dallas, Texas, 75246, United States
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Denton, Texas, 76210, United States
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Flower Mound, Texas, 75028, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77089, United States
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Paris, Texas, 75460, United States
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San Antonio, Texas, 78217, United States
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The Woodlands, Texas, 77380, United States
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Newport News, Virginia, 23601, United States
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Vancouver, Washington, 98684, United States
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Wenatchee, Washington, 98801, United States
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Redcliffe, Queensland, Australia
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Kurralta Park, South Australia, Australia
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Ballarat, Victoria, Australia
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Dobrich, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Kingston, Ontario, K7L 5P9, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Québec, G1S 4L8, Canada
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Tübingen, Germany
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Budapest, Hungary
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Szeged, Hungary
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Szekszárd, Hungary
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Szolnok, Hungary
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Carpi, Modena, Italy
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Castellanza, Varese, Italy
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Milan, Italy
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Pavia, Italy
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Reggio Emilia, Italy
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Kamogawa-shi, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Sapporo, Hokkaido, Japan
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Sendai, Miyagi, Japan
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Osaka, Osaka, Japan
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Chūōku, Tokyo-To, Japan
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Brzozów, Poland
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Opole, Poland
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Warsaw, Poland
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Wałbrzych, Poland
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Wieliszew, Poland
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Wroclaw, Poland
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Żory, Poland
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Chelyabinsk, Russia
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Krasnodar, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Pyatigorsk, Russia
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Ryazan, Russia
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Tomsk, Russia
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Goyang-si, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Busan, South Korea
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Seoul, South Korea
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Ulsan, South Korea
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Terrassa, Barcelona, Spain
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A Coruña, La Coruña, Spain
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Alcorcón, Madrid, Spain
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San Sebastián de los Reyes, Madrid, Spain
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Barcelona, Spain
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Burgos, Spain
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Girona, Spain
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Huelva, Spain
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Sakarya, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Tekirdağ, Turkey (Türkiye)
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Trabzon, Turkey (Türkiye)
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Van, Turkey (Türkiye)
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Huntingdon, Cambridgeshire, United Kingdom
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Peterborough, Cambridgeshire, United Kingdom
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Truro, Cornwall, United Kingdom
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Derby, Derbyshire, United Kingdom
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Exeter, Devon, United Kingdom
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Worthing, East Sussex, United Kingdom
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London, Greater London, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Lancaster, Lancashire, United Kingdom
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Stoke-on-Trent, Staffordshire, United Kingdom
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Warwick, Warwickshire, United Kingdom
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Wolverhampton, West Midlands, United Kingdom
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Huddersfield, West Yorkshire, United Kingdom
Related Publications (2)
Koh 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: 34467476DERIVEDO'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: 33109210DERIVED
Related Links
Biospecimen
Whole Blood and Archived Tumor Specimen (e.g. tumor tissue)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
March 13, 2017
Study Start
March 13, 2017
Primary Completion
May 20, 2019
Study Completion
May 20, 2019
Last Updated
May 20, 2020
Record last verified: 2020-05