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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03078036




Registration number
NCT03078036
Ethics application status
Date submitted
10/02/2017
Date registered
13/03/2017
Date last updated
25/06/2019

Titles & IDs
Public title
International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
Scientific title
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
Secondary ID [1] 0 0
D0816R00012
Universal Trial Number (UTN)
Trial acronym
BREAKOUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Germline BRCA Test (blood)
Other interventions - 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.


Other interventions: 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.)

Other interventions: 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
At one time point at inclusion in the study up to 12 months after the beginning of the study.
Secondary outcome [1] 0 0
Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer. - 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.
Timepoint [1] 0 0
2.5 years (30 months) since the beginning of the study.
Secondary outcome [2] 0 0
Progression free survival by line of therapy - 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.
Timepoint [2] 0 0
2.5 years (30 months) since the beginning of the study.
Secondary outcome [3] 0 0
Overall survival by line of therapy - 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.
Timepoint [3] 0 0
2.5 years (30 months) since the beginning of the study.

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).
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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NSW,QLD,SA,VIC
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Research Site - Concord
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Worcestershire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Quintiles; University of Tubingen - Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03078036
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Contact person for scientific queries

Summary results
Other publications