International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study (BREAKOUT)
19. maj 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
873
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Queensland
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Redcliffe, Queensland, Australien
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South Australia
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Kurralta Park, South Australia, Australien
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Victoria
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Ballarat, Victoria, Australien
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Dobrich, Bulgarien
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Ruse, Bulgarien
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Sofia, Bulgarien
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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 Føderation
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Krasnodar, Den Russiske Føderation
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Novosibirsk, Den Russiske Føderation
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Omsk, Den Russiske Føderation
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Pyatigorsk, Den Russiske Føderation
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Ryazan, Den Russiske Føderation
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Tomsk, Den Russiske Føderation
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Cambridgeshire
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Huntingdon, Cambridgeshire, Det Forenede Kongerige
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Peterborough, Cambridgeshire, Det Forenede Kongerige
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Cornwall
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Truro, Cornwall, Det Forenede Kongerige
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Derbyshire
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Derby, Derbyshire, Det Forenede Kongerige
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Devon
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Exeter, Devon, Det Forenede Kongerige
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East Sussex
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Worthing, East Sussex, Det Forenede Kongerige
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Greater London
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London, Greater London, Det Forenede Kongerige
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Lancashire
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Blackpool, Lancashire, Det Forenede Kongerige
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Lancaster, Lancashire, Det Forenede Kongerige
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Staffordshire
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Stoke on Trent, Staffordshire, Det Forenede Kongerige
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Warwickshire
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Warwick, Warwickshire, Det Forenede Kongerige
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West Midlands
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Wolverhampton, West Midlands, Det Forenede Kongerige
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West Yorkshire
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Huddersfield, West Yorkshire, Det Forenede Kongerige
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California
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Santa Barbara, California, Forenede Stater, 93105
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Colorado
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Denver, Colorado, Forenede Stater, 80218
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Florida
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Hialeah, Florida, Forenede Stater, 33012
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Texas
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Dallas, Texas, Forenede Stater, 75246
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Denton, Texas, Forenede Stater, 76210
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Flower Mound, Texas, Forenede Stater, 75028
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Houston, Texas, Forenede Stater, 77024
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Houston, Texas, Forenede Stater, 77089
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Paris, Texas, Forenede Stater, 75460
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San Antonio, Texas, Forenede Stater, 78217
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The Woodlands, Texas, Forenede Stater, 77380
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Virginia
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Newport News, Virginia, Forenede Stater, 23601
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Washington
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Vancouver, Washington, Forenede Stater, 98684
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Wenatchee, Washington, Forenede Stater, 98801
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Milano, Italien
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Pavia, Italien
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Reggio Emilia, Italien
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Modena
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Carpi, Modena, Italien
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Varese
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Castellanza, Varese, Italien
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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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Adana, Kalkun
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Ankara, Kalkun
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Antalya, Kalkun
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Diyarbakir, Kalkun
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Istanbul, Kalkun
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Izmir, Kalkun
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Kocaeli, Kalkun
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Sakarya, Kalkun
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Samsun, Kalkun
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Tekirdag, Kalkun
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Trabzon, Kalkun
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Van, Kalkun
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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, Spanien
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Burgos, Spanien
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Girona, Spanien
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Huelva, Spanien
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Barcelona
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Terrassa, Barcelona, Spanien
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La Coruña
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A Coruna, La Coruña, Spanien
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Madrid
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Alcorcon, Madrid, Spanien
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San Sebastian de los Reyes, Madrid, Spanien
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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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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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. marts 2017
Primær færdiggørelse (Faktiske)
20. maj 2019
Studieafslutning (Faktiske)
20. maj 2019
Datoer for studieregistrering
Først indsendt
10. februar 2017
Først indsendt, der opfyldte QC-kriterier
7. marts 2017
Først opslået (Faktiske)
13. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2020
Sidst verificeret
1. maj 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D0816R00012
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Atlas UniversityIkke rekrutterer endnuBrystkræft | Locally Advanced Breast Cancer (LABC)Tyrkiet (Türkiye)
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ETOP IBCSG Partners FoundationAfsluttetBreast Cancer Invasive NosItalien
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Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAfsluttetBreast Cancer Invasive NosSpanien
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Second Affiliated Hospital, School of Medicine,...RekrutteringTNBC, Triple Negative Breast CancerKina
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European Institute of OncologyAktiv, ikke rekrutterendeÆggelederkarcinom | Ovariekarcinom | Primært peritonealt karcinomItalien
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Mayo ClinicNational Institute of Allergy and Infectious Diseases (NIAID); National...AfsluttetFungemia | Bakteriæmi | BlodbaneinfektionForenede Stater
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