- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03078036
International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study (BREAKOUT)
BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Tubingen, Alemania
- Research Site
-
-
-
-
Queensland
-
Redcliffe, Queensland, Australia
- Research Site
-
-
South Australia
-
Kurralta Park, South Australia, Australia
- Research Site
-
-
Victoria
-
Ballarat, Victoria, Australia
- Research Site
-
-
-
-
-
Dobrich, Bulgaria
- Research Site
-
Ruse, Bulgaria
- Research Site
-
Sofia, Bulgaria
- Research Site
-
-
-
-
-
Quebec, Canadá, G1S 4L8
- Research Site
-
-
Ontario
-
Kingston, Ontario, Canadá, K7L 5P9
- Research Site
-
Kitchener, Ontario, Canadá, N2G 1G3
- Research Site
-
-
Quebec
-
Chicoutimi, Quebec, Canadá, G7H 5H6
- Research Site
-
-
-
-
-
Busan, Corea, república de
- Research Site
-
Seoul, Corea, república de
- Research Site
-
Ulsan, Corea, república de
- Research Site
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Corea, república de
- Research Site
-
Seongnam-si, Gyeonggi-do, Corea, república de
- Research Site
-
Seongnam-si,, Gyeonggi-do, Corea, república de
- Research Site
-
-
-
-
-
Barcelona, España
- Research Site
-
Burgos, España
- Research Site
-
Girona, España
- Research Site
-
Huelva, España
- Research Site
-
-
Barcelona
-
Terrassa, Barcelona, España
- Research Site
-
-
La Coruña
-
A Coruna, La Coruña, España
- Research Site
-
-
Madrid
-
Alcorcon, Madrid, España
- Research Site
-
San Sebastian de los Reyes, Madrid, España
- Research Site
-
-
-
-
California
-
Santa Barbara, California, Estados Unidos, 93105
- Research Site
-
-
Colorado
-
Denver, Colorado, Estados Unidos, 80218
- Research Site
-
-
Florida
-
Hialeah, Florida, Estados Unidos, 33012
- Research Site
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75246
- Research Site
-
Denton, Texas, Estados Unidos, 76210
- Research Site
-
Flower Mound, Texas, Estados Unidos, 75028
- Research Site
-
Houston, Texas, Estados Unidos, 77024
- Research Site
-
Houston, Texas, Estados Unidos, 77089
- Research Site
-
Paris, Texas, Estados Unidos, 75460
- Research Site
-
San Antonio, Texas, Estados Unidos, 78217
- Research Site
-
The Woodlands, Texas, Estados Unidos, 77380
- Research Site
-
-
Virginia
-
Newport News, Virginia, Estados Unidos, 23601
- Research Site
-
-
Washington
-
Vancouver, Washington, Estados Unidos, 98684
- Research Site
-
Wenatchee, Washington, Estados Unidos, 98801
- Research Site
-
-
-
-
-
Chelyabinsk, Federación Rusa
- Research Site
-
Krasnodar, Federación Rusa
- Research Site
-
Novosibirsk, Federación Rusa
- Research Site
-
Omsk, Federación Rusa
- Research Site
-
Pyatigorsk, Federación Rusa
- Research Site
-
Ryazan, Federación Rusa
- Research Site
-
Tomsk, Federación Rusa
- Research Site
-
-
-
-
-
Budapest, Hungría
- Research Site
-
Szeged, Hungría
- Research Site
-
Szekszard, Hungría
- Research Site
-
Szolnok, Hungría
- Research Site
-
-
-
-
-
Milano, Italia
- Research Site
-
Pavia, Italia
- Research Site
-
Reggio Emilia, Italia
- Research Site
-
-
Modena
-
Carpi, Modena, Italia
- Research Site
-
-
Varese
-
Castellanza, Varese, Italia
- Research Site
-
-
-
-
Chiba-Ken
-
Kamogawa-shi, Chiba-Ken, Japón
- Research Site
-
-
Ehime-Ken
-
Matsuyama-shi, Ehime-Ken, Japón
- Research Site
-
-
Fukuoka-Ken
-
Fukuoka-shi, Fukuoka-Ken, Japón
- Research Site
-
-
Hokkaido
-
Sapporo-shi, Hokkaido, Japón
- Research Site
-
-
Miyagi-Ken
-
Sendai-shi, Miyagi-Ken, Japón
- Research Site
-
-
Osaka-Fu
-
Osaka-shi, Osaka-Fu, Japón
- Research Site
-
-
Tokyo-To
-
Chuo-ku, Tokyo-To, Japón
- Research Site
-
-
-
-
-
Adana, Pavo
- Research Site
-
Ankara, Pavo
- Research Site
-
Antalya, Pavo
- Research Site
-
Diyarbakir, Pavo
- Research Site
-
Istanbul, Pavo
- Research Site
-
Izmir, Pavo
- Research Site
-
Kocaeli, Pavo
- Research Site
-
Sakarya, Pavo
- Research Site
-
Samsun, Pavo
- Research Site
-
Tekirdag, Pavo
- Research Site
-
Trabzon, Pavo
- Research Site
-
Van, Pavo
- Research Site
-
-
-
-
-
Brzozow, Polonia
- Research Site
-
Opole, Polonia
- Research Site
-
Walbrzych, Polonia
- Research Site
-
Warszawa, Polonia
- Research Site
-
Wieliszew, Polonia
- Research Site
-
Wroclaw, Polonia
- Research Site
-
Zory, Polonia
- Research Site
-
-
-
-
Cambridgeshire
-
Huntingdon, Cambridgeshire, Reino Unido
- Research Site
-
Peterborough, Cambridgeshire, Reino Unido
- Research Site
-
-
Cornwall
-
Truro, Cornwall, Reino Unido
- Research Site
-
-
Derbyshire
-
Derby, Derbyshire, Reino Unido
- Research Site
-
-
Devon
-
Exeter, Devon, Reino Unido
- Research Site
-
-
East Sussex
-
Worthing, East Sussex, Reino Unido
- Research Site
-
-
Greater London
-
London, Greater London, Reino Unido
- Research Site
-
-
Lancashire
-
Blackpool, Lancashire, Reino Unido
- Research Site
-
Lancaster, Lancashire, Reino Unido
- Research Site
-
-
Staffordshire
-
Stoke on Trent, Staffordshire, Reino Unido
- Research Site
-
-
Warwickshire
-
Warwick, Warwickshire, Reino Unido
- Research Site
-
-
West Midlands
-
Wolverhampton, West Midlands, Reino Unido
- Research Site
-
-
West Yorkshire
-
Huddersfield, West Yorkshire, Reino Unido
- Research Site
-
-
-
-
-
Changhua, Taiwán
- Research Site
-
Kaohsiung, Taiwán
- Research Site
-
Taichung, Taiwán
- Research Site
-
Tainan, Taiwán
- Research Site
-
Taipei, Taiwán
- Research Site
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
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.
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
Periodo de tiempo: At one time point at inclusion in the study up to 12 months after the beginning of the study.
|
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).
|
At one time point at inclusion in the study up to 12 months after the beginning of the study.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
Periodo de tiempo: 2.5 years (30 months) since the beginning of the study.
|
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.
|
2.5 years (30 months) since the beginning of the study.
|
Progression free survival by line of therapy
Periodo de tiempo: 2.5 years (30 months) since the beginning of the study.
|
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.
|
2.5 years (30 months) since the beginning of the study.
|
Overall survival by line of therapy
Periodo de tiempo: 2.5 years (30 months) since the beginning of the study.
|
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.
|
2.5 years (30 months) since the beginning of the study.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D0816R00012
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer de mama
-
University of Alabama at BirminghamMammotomeAún no reclutandoPacientes programadas para la localización de Breast ScoutEstados Unidos
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University y otros colaboradoresTerminadoLa guía de aplicación clínica de Conebeam Breast CTPorcelana
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos