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

19 maggio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

873

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • Queensland
      • Redcliffe, Queensland, Australia
        • Research Site
    • South Australia
      • Kurralta Park, South Australia, Australia
        • Research Site
    • Victoria
      • Ballarat, Victoria, Australia
        • Research Site
  • Bulgaria
      • Dobrich, Bulgaria
        • Research Site
      • Ruse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Canada
      • Quebec, Canada, G1S 4L8
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Research Site
      • Kitchener, Ontario, Canada, N2G 1G3
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Research Site
  • Corea, Repubblica di
      • Busan, Corea, Repubblica di
        • Research Site
      • Seoul, Corea, Repubblica di
        • Research Site
      • Ulsan, Corea, Repubblica di
        • Research Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Corea, Repubblica di
        • Research Site
      • Seongnam-si, Gyeonggi-do, Corea, Repubblica di
        • Research Site
      • Seongnam-si,, Gyeonggi-do, Corea, Repubblica di
        • Research Site
  • Federazione Russa
      • Chelyabinsk, Federazione Russa
        • Research Site
      • Krasnodar, Federazione Russa
        • Research Site
      • Novosibirsk, Federazione Russa
        • Research Site
      • Omsk, Federazione Russa
        • Research Site
      • Pyatigorsk, Federazione Russa
        • Research Site
      • Ryazan, Federazione Russa
        • Research Site
      • Tomsk, Federazione Russa
        • Research Site
  • Germania
      • Tubingen, Germania
        • Research Site
  • Giappone
    • Chiba-Ken
      • Kamogawa-shi, Chiba-Ken, Giappone
        • Research Site
    • Ehime-Ken
      • Matsuyama-shi, Ehime-Ken, Giappone
        • Research Site
    • Fukuoka-Ken
      • Fukuoka-shi, Fukuoka-Ken, Giappone
        • Research Site
    • Hokkaido
      • Sapporo-shi, Hokkaido, Giappone
        • Research Site
    • Miyagi-Ken
      • Sendai-shi, Miyagi-Ken, Giappone
        • Research Site
    • Osaka-Fu
      • Osaka-shi, Osaka-Fu, Giappone
        • Research Site
    • Tokyo-To
      • Chuo-ku, Tokyo-To, Giappone
        • Research Site
  • Italia
      • 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
  • Polonia
      • 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
  • Regno Unito
    • Cambridgeshire
      • Huntingdon, Cambridgeshire, Regno Unito
        • Research Site
      • Peterborough, Cambridgeshire, Regno Unito
        • Research Site
    • Cornwall
      • Truro, Cornwall, Regno Unito
        • Research Site
    • Derbyshire
      • Derby, Derbyshire, Regno Unito
        • Research Site
    • Devon
      • Exeter, Devon, Regno Unito
        • Research Site
    • East Sussex
      • Worthing, East Sussex, Regno Unito
        • Research Site
    • Greater London
      • London, Greater London, Regno Unito
        • Research Site
    • Lancashire
      • Blackpool, Lancashire, Regno Unito
        • Research Site
      • Lancaster, Lancashire, Regno Unito
        • Research Site
    • Staffordshire
      • Stoke on Trent, Staffordshire, Regno Unito
        • Research Site
    • Warwickshire
      • Warwick, Warwickshire, Regno Unito
        • Research Site
    • West Midlands
      • Wolverhampton, West Midlands, Regno Unito
        • Research Site
    • West Yorkshire
      • Huddersfield, West Yorkshire, Regno Unito
        • Research Site
  • Spagna
      • Barcelona, Spagna
        • Research Site
      • Burgos, Spagna
        • Research Site
      • Girona, Spagna
        • Research Site
      • Huelva, Spagna
        • Research Site
    • Barcelona
      • Terrassa, Barcelona, Spagna
        • Research Site
    • La Coruña
      • A Coruna, La Coruña, Spagna
        • Research Site
    • Madrid
      • Alcorcon, Madrid, Spagna
        • Research Site
      • San Sebastian de los Reyes, Madrid, Spagna
        • Research Site
  • Stati Uniti
    • California
      • Santa Barbara, California, Stati Uniti, 93105
        • Research Site
    • Colorado
      • Denver, Colorado, Stati Uniti, 80218
        • Research Site
    • Florida
      • Hialeah, Florida, Stati Uniti, 33012
        • Research Site
    • Texas
      • Dallas, Texas, Stati Uniti, 75246
        • Research Site
      • Denton, Texas, Stati Uniti, 76210
        • Research Site
      • Flower Mound, Texas, Stati Uniti, 75028
        • Research Site
      • Houston, Texas, Stati Uniti, 77024
        • Research Site
      • Houston, Texas, Stati Uniti, 77089
        • Research Site
      • Paris, Texas, Stati Uniti, 75460
        • Research Site
      • San Antonio, Texas, Stati Uniti, 78217
        • Research Site
      • The Woodlands, Texas, Stati Uniti, 77380
        • Research Site
    • Virginia
      • Newport News, Virginia, Stati Uniti, 23601
        • Research Site
    • Washington
      • Vancouver, Washington, Stati Uniti, 98684
        • Research Site
      • Wenatchee, Washington, Stati Uniti, 98801
        • Research Site
  • Tacchino
      • Adana, Tacchino
        • Research Site
      • Ankara, Tacchino
        • Research Site
      • Antalya, Tacchino
        • Research Site
      • Diyarbakir, Tacchino
        • Research Site
      • Istanbul, Tacchino
        • Research Site
      • Izmir, Tacchino
        • Research Site
      • Kocaeli, Tacchino
        • Research Site
      • Sakarya, Tacchino
        • Research Site
      • Samsun, Tacchino
        • Research Site
      • Tekirdag, Tacchino
        • Research Site
      • Trabzon, Tacchino
        • Research Site
      • Van, Tacchino
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
  • Ungheria
      • Budapest, Ungheria
        • Research Site
      • Szeged, Ungheria
        • Research Site
      • Szekszard, Ungheria
        • Research Site
      • Szolnok, Ungheria
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Genetico: 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.)
Genetico: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
BRCA Mutational status (BRCA1 mutated and/or BRCA2 mutated or BRCA wild type).
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Descriptive statistics for treatments administered by line of therapy from 1st line metastatic breast cancer.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Collaboratori

Quintiles; University of Tubingen - Germany

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 marzo 2017

Completamento primario (Effettivo)

20 maggio 2019

Completamento dello studio (Effettivo)

20 maggio 2019

Date di iscrizione allo studio

Primo inviato

10 febbraio 2017

Primo inviato che soddisfa i criteri di controllo qualità

7 marzo 2017

Primo Inserito (Effettivo)

13 marzo 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2020

Ultimo verificato

1 maggio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D0816R00012

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su Germline BRCA Test (blood)

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CROs in Malaysia

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Malattie rare

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