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International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study (BREAKOUT)

19 de mayo de 2020 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

873

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

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

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

Centers for primary care of metastatic HER2-ve breast cancer patients

Descripción

Inclusion Criteria:

  1. Provision of signed, written and dated informed consent.
  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:

  1. Previous enrolment in this study.
  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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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:

  • 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.

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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de marzo de 2017

Finalización primaria (Actual)

20 de mayo de 2019

Finalización del estudio (Actual)

20 de mayo de 2019

Fechas de registro del estudio

Enviado por primera vez

10 de febrero de 2017

Primero enviado que cumplió con los criterios de control de calidad

7 de marzo de 2017

Publicado por primera vez (Actual)

13 de marzo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

19 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • D0816R00012

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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