International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study
NCT ID: NCT03078036
Last Updated: 2020-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
873 participants
OBSERVATIONAL
2017-03-13
2019-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
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.)
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.
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.
Interventions
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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.)
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.
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.
Eligibility Criteria
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Inclusion Criteria
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).
Exclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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Quintiles; University of Tubingen - Germany
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Santa Barbara, California, United States
Research Site
Denver, Colorado, United States
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Hialeah, Florida, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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Flower Mound, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Paris, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Newport News, Virginia, United States
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Vancouver, Washington, United States
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Wenatchee, Washington, 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, Canada
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Kitchener, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Québec, , 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 City, , 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)
Research Site
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
Research Site
Huddersfield, West Yorkshire, United Kingdom
Countries
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References
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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.
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.
Related Links
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Other Identifiers
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D0816R00012
Identifier Type: -
Identifier Source: org_study_id
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