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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03078036
Registration number
NCT03078036
Ethics application status
Date submitted
10/02/2017
Date registered
13/03/2017
Titles & IDs
Public title
International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
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Scientific title
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
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Secondary ID [1]
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D0816R00012
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Universal Trial Number (UTN)
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Trial acronym
BREAKOUT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - Germline BRCA Test (blood)
Treatment: Other - FoundationOne Dx Genomic Profile (archival Tumour Specimen)
Other interventions - Follow-up
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.
Treatment: Other: Germline BRCA Test (blood)
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.)
Treatment: Other: FoundationOne Dx Genomic Profile (archival Tumour Specimen)
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.
Other interventions: Follow-up
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.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
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Assessment method [1]
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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).
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Timepoint [1]
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At one time point at inclusion in the study up to 12 months after the beginning of the study.
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Secondary outcome [1]
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Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
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Assessment method [1]
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Treatment patterns will be described by line of therapy. Treatment combinations, number of cycles per line, schedules, durations, and reason for discontinuation will be summarized descriptively.
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Timepoint [1]
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2.5 years (30 months) since the beginning of the study.
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Secondary outcome [2]
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Progression free survival by line of therapy
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Assessment method [2]
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Progression free survival (in months) for each line of treatment, defined as the time from the date of start of each line of treatment to the documented date of progression as determined by the investigator (radiologic or symptomatic), or death from any cause in the absence of progression.
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Timepoint [2]
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2.5 years (30 months) since the beginning of the study.
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Secondary outcome [3]
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Overall survival by line of therapy
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Assessment method [3]
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Overall survival (OS) defined as the time from the start date of first line chemotherapy in the metastatic setting until the date of death due to any cause, assessed up to 30 months. In addition, OS since diagnosis of metastatic breast cancer and OS since the start of each subsequent therapy will be estimated.
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Timepoint [3]
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2.5 years (30 months) since the beginning of the study.
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Eligibility
Key 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).
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Minimum age
18
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/05/2019
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Sample size
Target
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Accrual to date
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Final
873
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Redcliffe
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Research Site - Kurralta Park
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Research Site - Ballarat
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- Redcliffe
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- Kurralta Park
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Recruitment postcode(s) [3]
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- Ballarat
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Funding & Sponsors
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Commercial sector/industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Quintiles; University of Tubingen - Germany
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03078036
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Trial related presentations / publications
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. Erratum In: Breast Cancer. 2022 Jan;29(1):189-190. doi: 10.1007/s12282-021-01299-w. O'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.
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Public notes
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Contacts
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03078036