International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study (BREAKOUT)
19 mai 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
873
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Tubingen, Allemagne
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Queensland
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Redcliffe, Queensland, Australie
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South Australia
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Kurralta Park, South Australia, Australie
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Victoria
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Ballarat, Victoria, Australie
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Dobrich, Bulgarie
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Ruse, Bulgarie
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Sofia, Bulgarie
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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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Busan, Corée, République de
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Seoul, Corée, République de
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Ulsan, Corée, République de
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Corée, République de
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Seongnam-si, Gyeonggi-do, Corée, République de
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Seongnam-si,, Gyeonggi-do, Corée, République de
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Barcelona, Espagne
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Burgos, Espagne
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Girona, Espagne
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Huelva, Espagne
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Barcelona
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Terrassa, Barcelona, Espagne
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La Coruña
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A Coruna, La Coruña, Espagne
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Madrid
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Alcorcon, Madrid, Espagne
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San Sebastian de los Reyes, Madrid, Espagne
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Chelyabinsk, Fédération Russe
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Krasnodar, Fédération Russe
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Novosibirsk, Fédération Russe
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Omsk, Fédération Russe
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Pyatigorsk, Fédération Russe
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Ryazan, Fédération Russe
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Tomsk, Fédération Russe
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Budapest, Hongrie
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Szeged, Hongrie
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Szekszard, Hongrie
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Szolnok, Hongrie
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Milano, Italie
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Pavia, Italie
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Reggio Emilia, Italie
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Modena
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Carpi, Modena, Italie
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Varese
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Castellanza, Varese, Italie
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Chiba-Ken
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Kamogawa-shi, Chiba-Ken, Japon
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Ehime-Ken
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Matsuyama-shi, Ehime-Ken, Japon
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Fukuoka-Ken
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Fukuoka-shi, Fukuoka-Ken, Japon
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Hokkaido
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Sapporo-shi, Hokkaido, Japon
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Miyagi-Ken
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Sendai-shi, Miyagi-Ken, Japon
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Osaka-Fu
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Osaka-shi, Osaka-Fu, Japon
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Tokyo-To
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Chuo-ku, Tokyo-To, Japon
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Brzozow, Pologne
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Opole, Pologne
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Walbrzych, Pologne
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Warszawa, Pologne
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Wieliszew, Pologne
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Wroclaw, Pologne
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Zory, Pologne
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Cambridgeshire
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Huntingdon, Cambridgeshire, Royaume-Uni
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Peterborough, Cambridgeshire, Royaume-Uni
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Cornwall
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Truro, Cornwall, Royaume-Uni
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Derbyshire
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Derby, Derbyshire, Royaume-Uni
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Devon
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Exeter, Devon, Royaume-Uni
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East Sussex
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Worthing, East Sussex, Royaume-Uni
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Greater London
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London, Greater London, Royaume-Uni
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Lancashire
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Blackpool, Lancashire, Royaume-Uni
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Lancaster, Lancashire, Royaume-Uni
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Staffordshire
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Stoke on Trent, Staffordshire, Royaume-Uni
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Warwickshire
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Warwick, Warwickshire, Royaume-Uni
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West Midlands
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Wolverhampton, West Midlands, Royaume-Uni
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West Yorkshire
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Huddersfield, West Yorkshire, Royaume-Uni
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Changhua, Taïwan
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Kaohsiung, Taïwan
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Taichung, Taïwan
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Tainan, Taïwan
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Taipei, Taïwan
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Adana, Turquie
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Ankara, Turquie
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Antalya, Turquie
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Diyarbakir, Turquie
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Istanbul, Turquie
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Izmir, Turquie
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Kocaeli, Turquie
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Sakarya, Turquie
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Samsun, Turquie
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Tekirdag, Turquie
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Trabzon, Turquie
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Van, Turquie
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California
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Santa Barbara, California, États-Unis, 93105
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Colorado
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Denver, Colorado, États-Unis, 80218
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Florida
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Hialeah, Florida, États-Unis, 33012
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Texas
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Dallas, Texas, États-Unis, 75246
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Denton, Texas, États-Unis, 76210
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Flower Mound, Texas, États-Unis, 75028
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Houston, Texas, États-Unis, 77024
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Houston, Texas, États-Unis, 77089
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Paris, Texas, États-Unis, 75460
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San Antonio, Texas, États-Unis, 78217
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The Woodlands, Texas, États-Unis, 77380
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Virginia
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Newport News, Virginia, États-Unis, 23601
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Washington
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Vancouver, Washington, États-Unis, 98684
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Wenatchee, Washington, États-Unis, 98801
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Centers for primary care of metastatic HER2-ve breast cancer patients
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 mars 2017
Achèvement primaire (Réel)
20 mai 2019
Achèvement de l'étude (Réel)
20 mai 2019
Dates d'inscription aux études
Première soumission
10 février 2017
Première soumission répondant aux critères de contrôle qualité
7 mars 2017
Première publication (Réel)
13 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 mai 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 mai 2020
Dernière vérification
1 mai 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D0816R00012
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .