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

19 maj 2020 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

873

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • Queensland
      • Redcliffe, Queensland, Australien
        • Research Site
    • South Australia
      • Kurralta Park, South Australia, Australien
        • Research Site
    • Victoria
      • Ballarat, Victoria, Australien
        • Research Site
  • Bulgarien
      • Dobrich, Bulgarien
        • Research Site
      • Ruse, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Site
  • Förenta staterna
    • California
      • Santa Barbara, California, Förenta staterna, 93105
        • Research Site
    • Colorado
      • Denver, Colorado, Förenta staterna, 80218
        • Research Site
    • Florida
      • Hialeah, Florida, Förenta staterna, 33012
        • Research Site
    • Texas
      • Dallas, Texas, Förenta staterna, 75246
        • Research Site
      • Denton, Texas, Förenta staterna, 76210
        • Research Site
      • Flower Mound, Texas, Förenta staterna, 75028
        • Research Site
      • Houston, Texas, Förenta staterna, 77024
        • Research Site
      • Houston, Texas, Förenta staterna, 77089
        • Research Site
      • Paris, Texas, Förenta staterna, 75460
        • Research Site
      • San Antonio, Texas, Förenta staterna, 78217
        • Research Site
      • The Woodlands, Texas, Förenta staterna, 77380
        • Research Site
    • Virginia
      • Newport News, Virginia, Förenta staterna, 23601
        • Research Site
    • Washington
      • Vancouver, Washington, Förenta staterna, 98684
        • Research Site
      • Wenatchee, Washington, Förenta staterna, 98801
        • Research Site
  • Italien
      • Milano, Italien
        • Research Site
      • Pavia, Italien
        • Research Site
      • Reggio Emilia, Italien
        • Research Site
    • Modena
      • Carpi, Modena, Italien
        • Research Site
    • Varese
      • Castellanza, Varese, Italien
        • Research Site
  • Japan
    • Chiba-Ken
      • Kamogawa-shi, Chiba-Ken, Japan
        • Research Site
    • Ehime-Ken
      • Matsuyama-shi, Ehime-Ken, Japan
        • Research Site
    • Fukuoka-Ken
      • Fukuoka-shi, Fukuoka-Ken, Japan
        • Research Site
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
        • Research Site
    • Miyagi-Ken
      • Sendai-shi, Miyagi-Ken, Japan
        • Research Site
    • Osaka-Fu
      • Osaka-shi, Osaka-Fu, Japan
        • Research Site
    • Tokyo-To
      • Chuo-ku, Tokyo-To, Japan
        • Research Site
  • Kalkon
      • Adana, Kalkon
        • Research Site
      • Ankara, Kalkon
        • Research Site
      • Antalya, Kalkon
        • Research Site
      • Diyarbakir, Kalkon
        • Research Site
      • Istanbul, Kalkon
        • Research Site
      • Izmir, Kalkon
        • Research Site
      • Kocaeli, Kalkon
        • Research Site
      • Sakarya, Kalkon
        • Research Site
      • Samsun, Kalkon
        • Research Site
      • Tekirdag, Kalkon
        • Research Site
      • Trabzon, Kalkon
        • Research Site
      • Van, Kalkon
        • Research Site
  • Kanada
      • Quebec, Kanada, G1S 4L8
        • Research Site
    • Ontario
      • Kingston, Ontario, Kanada, K7L 5P9
        • Research Site
      • Kitchener, Ontario, Kanada, N2G 1G3
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Kanada, G7H 5H6
        • Research Site
  • Korea, Republiken av
      • Busan, Korea, Republiken av
        • Research Site
      • Seoul, Korea, Republiken av
        • Research Site
      • Ulsan, Korea, Republiken av
        • Research Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republiken av
        • Research Site
      • Seongnam-si, Gyeonggi-do, Korea, Republiken av
        • Research Site
      • Seongnam-si,, Gyeonggi-do, Korea, Republiken av
        • Research Site
  • Polen
      • Brzozow, Polen
        • Research Site
      • Opole, Polen
        • Research Site
      • Walbrzych, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Wieliszew, Polen
        • Research Site
      • Wroclaw, Polen
        • Research Site
      • Zory, Polen
        • Research Site
  • Ryska Federationen
      • Chelyabinsk, Ryska Federationen
        • Research Site
      • Krasnodar, Ryska Federationen
        • Research Site
      • Novosibirsk, Ryska Federationen
        • Research Site
      • Omsk, Ryska Federationen
        • Research Site
      • Pyatigorsk, Ryska Federationen
        • Research Site
      • Ryazan, Ryska Federationen
        • Research Site
      • Tomsk, Ryska Federationen
        • Research Site
  • Spanien
      • Barcelona, Spanien
        • Research Site
      • Burgos, Spanien
        • Research Site
      • Girona, Spanien
        • Research Site
      • Huelva, Spanien
        • Research Site
    • Barcelona
      • Terrassa, Barcelona, Spanien
        • Research Site
    • La Coruña
      • A Coruna, La Coruña, Spanien
        • Research Site
    • Madrid
      • Alcorcon, Madrid, Spanien
        • Research Site
      • San Sebastian de los Reyes, Madrid, Spanien
        • Research Site
  • Storbritannien
    • Cambridgeshire
      • Huntingdon, Cambridgeshire, Storbritannien
        • Research Site
      • Peterborough, Cambridgeshire, Storbritannien
        • Research Site
    • Cornwall
      • Truro, Cornwall, Storbritannien
        • Research Site
    • Derbyshire
      • Derby, Derbyshire, Storbritannien
        • Research Site
    • Devon
      • Exeter, Devon, Storbritannien
        • Research Site
    • East Sussex
      • Worthing, East Sussex, Storbritannien
        • Research Site
    • Greater London
      • London, Greater London, Storbritannien
        • Research Site
    • Lancashire
      • Blackpool, Lancashire, Storbritannien
        • Research Site
      • Lancaster, Lancashire, Storbritannien
        • Research Site
    • Staffordshire
      • Stoke on Trent, Staffordshire, Storbritannien
        • Research Site
    • Warwickshire
      • Warwick, Warwickshire, Storbritannien
        • Research Site
    • West Midlands
      • Wolverhampton, West Midlands, Storbritannien
        • Research Site
    • West Yorkshire
      • Huddersfield, West Yorkshire, Storbritannien
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
  • Tyskland
      • Tubingen, Tyskland
        • Research Site
  • Ungern
      • Budapest, Ungern
        • Research Site
      • Szeged, Ungern
        • Research Site
      • Szekszard, Ungern
        • Research Site
      • Szolnok, Ungern
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Genetisk: Germline BRCA Test (blood)
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.)
Genetisk: FoundationOne Dx Genomic Profile (archival Tumour Specimen)

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.
Övrig: Follow-up

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Samarbetspartners

Quintiles; University of Tubingen - Germany

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 mars 2017

Primärt slutförande (Faktisk)

20 maj 2019

Avslutad studie (Faktisk)

20 maj 2019

Studieregistreringsdatum

Först inskickad

10 februari 2017

Först inskickad som uppfyllde QC-kriterierna

7 mars 2017

Första postat (Faktisk)

13 mars 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 maj 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 maj 2020

Senast verifierad

1 maj 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D0816R00012

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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