International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study (BREAKOUT)
19. mai 2020 oppdatert av: AstraZeneca
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Background/Rationale: Within the setting of metastatic human epidermal growth factor receptor 2 negative (HER2-ve) breast cancer limited epidemiological data exist on the prevalence of pathogenic mutations of breast cancer susceptibility gene (BRCA) and other homologous recombination repair (HRR) genes.
There are also limited data on the treatments and clinical outcomes of patients with such germline and somatic genetic profiles, particularly within this setting.
This epidemiologic study will estimate the prevalence of germline breast susceptibility gene (gBRCA) mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy and, at that time, are considered to have exhausted hormone therapy options (if hormone receptor positive [HR+ve]), per investigator's opinion.
Among those patients with a gBRCA gene mutation, treatment patterns and clinical outcomes will be described.
This study may also explore the prevalence of somatic BRCA (sBRCA) mutations and other HRR gene mutations among metastatic HER2-ve patients who have commenced 1st line systemic cytotoxic chemotherapy.
The treatment patterns and clinical outcomes may be described among those patients with a sBRCA gene mutation and those with other HRR gene mutations.
Studietype
Observasjonsmessig
Registrering (Faktiske)
873
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Queensland
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Redcliffe, Queensland, Australia
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South Australia
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Kurralta Park, South Australia, Australia
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Victoria
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Ballarat, Victoria, Australia
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Dobrich, Bulgaria
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Ruse, Bulgaria
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Sofia, Bulgaria
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Quebec, Canada, G1S 4L8
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Ontario
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Kingston, Ontario, Canada, K7L 5P9
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Kitchener, Ontario, Canada, N2G 1G3
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Chelyabinsk, Den russiske føderasjonen
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Krasnodar, Den russiske føderasjonen
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Novosibirsk, Den russiske føderasjonen
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Omsk, Den russiske føderasjonen
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Pyatigorsk, Den russiske føderasjonen
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Ryazan, Den russiske føderasjonen
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Tomsk, Den russiske føderasjonen
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California
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Santa Barbara, California, Forente stater, 93105
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Colorado
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Denver, Colorado, Forente stater, 80218
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Florida
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Hialeah, Florida, Forente stater, 33012
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Texas
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Dallas, Texas, Forente stater, 75246
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Denton, Texas, Forente stater, 76210
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Flower Mound, Texas, Forente stater, 75028
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Houston, Texas, Forente stater, 77024
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Houston, Texas, Forente stater, 77089
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Paris, Texas, Forente stater, 75460
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San Antonio, Texas, Forente stater, 78217
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The Woodlands, Texas, Forente stater, 77380
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Virginia
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Newport News, Virginia, Forente stater, 23601
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Washington
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Vancouver, Washington, Forente stater, 98684
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Wenatchee, Washington, Forente stater, 98801
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Milano, Italia
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Pavia, Italia
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Reggio Emilia, Italia
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Modena
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Carpi, Modena, Italia
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Varese
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Castellanza, Varese, Italia
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Chiba-Ken
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Kamogawa-shi, Chiba-Ken, Japan
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Ehime-Ken
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Matsuyama-shi, Ehime-Ken, Japan
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Fukuoka-Ken
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Fukuoka-shi, Fukuoka-Ken, Japan
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Hokkaido
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Sapporo-shi, Hokkaido, Japan
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Miyagi-Ken
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Sendai-shi, Miyagi-Ken, Japan
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Osaka-Fu
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Osaka-shi, Osaka-Fu, Japan
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Tokyo-To
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Chuo-ku, Tokyo-To, Japan
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Busan, Korea, Republikken
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Seoul, Korea, Republikken
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Ulsan, Korea, Republikken
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republikken
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Seongnam-si, Gyeonggi-do, Korea, Republikken
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Seongnam-si,, Gyeonggi-do, Korea, Republikken
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Brzozow, Polen
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Opole, Polen
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Walbrzych, Polen
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Warszawa, Polen
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Wieliszew, Polen
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Wroclaw, Polen
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Zory, Polen
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Barcelona, Spania
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Burgos, Spania
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Girona, Spania
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Huelva, Spania
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Barcelona
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Terrassa, Barcelona, Spania
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La Coruña
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A Coruna, La Coruña, Spania
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Madrid
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Alcorcon, Madrid, Spania
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San Sebastian de los Reyes, Madrid, Spania
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Cambridgeshire
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Huntingdon, Cambridgeshire, Storbritannia
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Peterborough, Cambridgeshire, Storbritannia
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Cornwall
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Truro, Cornwall, Storbritannia
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Derbyshire
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Derby, Derbyshire, Storbritannia
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Devon
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Exeter, Devon, Storbritannia
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East Sussex
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Worthing, East Sussex, Storbritannia
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Greater London
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London, Greater London, Storbritannia
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Lancashire
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Blackpool, Lancashire, Storbritannia
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Lancaster, Lancashire, Storbritannia
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Staffordshire
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Stoke on Trent, Staffordshire, Storbritannia
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Warwickshire
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Warwick, Warwickshire, Storbritannia
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West Midlands
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Wolverhampton, West Midlands, Storbritannia
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West Yorkshire
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Huddersfield, West Yorkshire, Storbritannia
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Changhua, Taiwan
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Adana, Tyrkia
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Ankara, Tyrkia
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Antalya, Tyrkia
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Diyarbakir, Tyrkia
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Istanbul, Tyrkia
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Izmir, Tyrkia
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Kocaeli, Tyrkia
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Sakarya, Tyrkia
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Samsun, Tyrkia
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Tekirdag, Tyrkia
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Trabzon, Tyrkia
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Van, Tyrkia
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Tubingen, Tyskland
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Budapest, Ungarn
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Szeged, Ungarn
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Szekszard, Ungarn
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Szolnok, Ungarn
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Centers for primary care of metastatic HER2-ve breast cancer patients
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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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:
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
Tidsramme: At one time point at inclusion in the study up to 12 months after the beginning of the study.
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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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At one time point at inclusion in the study up to 12 months after the beginning of the study.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
Tidsramme: 2.5 years (30 months) since the beginning of the study.
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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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2.5 years (30 months) since the beginning of the study.
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Progression free survival by line of therapy
Tidsramme: 2.5 years (30 months) since the beginning of the study.
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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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2.5 years (30 months) since the beginning of the study.
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Overall survival by line of therapy
Tidsramme: 2.5 years (30 months) since the beginning of the study.
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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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2.5 years (30 months) since the beginning of the study.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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. 2021 Sep 25;:
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. mars 2017
Primær fullføring (Faktiske)
20. mai 2019
Studiet fullført (Faktiske)
20. mai 2019
Datoer for studieregistrering
Først innsendt
10. februar 2017
Først innsendt som oppfylte QC-kriteriene
7. mars 2017
Først lagt ut (Faktiske)
13. mars 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2020
Sist bekreftet
1. mai 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D0816R00012
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .