UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029029 |
|---|---|
| Receipt number | R000033209 |
| Scientific Title | International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study |
| Date of disclosure of the study information | 2017/09/06 |
| Last modified on | 2023/06/26 16:23:24 |
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Basic information
Public title
International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
Acronym
BREAKOUT
Scientific Title
International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
Scientific Title:Acronym
BREAKOUT
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To estimate the prevalence of gBRCA gene mutations among the metastatic HER2-ve breast cancer patient population.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the prevalence of gBRCA gene mutations
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
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).
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.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AstraZeneca K.K. |
Organization
Medical
Division name
Medical Evidence & Observational Research
Zip code
Address
Grand Front Osaka Tower B3-1, Ofuka-cho, Kita-ku, Osaka
TEL
06-7711-3714
Tatsunori.Jinnai@astrazeneca.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | AstraZeneca K.K. |
Organization
Medical
Division name
Medical Evidence & Observational Research
Zip code
Address
Grand Front Osaka Tower B3-1, Ofuka-cho, Kita-ku, Osaka
TEL
06-7711-3714
Homepage URL
Tatsunori.Jinnai@astrazeneca.com
Sponsor or person
Institute
AstraZeneca K.K.
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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.
Management information
Registered date
| 2017 | Year | 09 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033209
