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CAMBRIA-1

A phase iii, open-label, randomised study to assess the efficacy and safety of extended therapy with camizestrant (azd9833, a next generation, oral selective estrogen receptor degrader) versus standard endocrine therapy (aromatase inhibitor or tamoxifen) in patients with er+/her2- early breast cancer and an intermediate or high risk of recurrence who have completed definitive locoregional therapy and at least 2 years of standard adjuvant endocrine-based therapy without disease recurrence (cambria-1)

ClinicalTrials reference: NCT05774951
Cancer
sein
camizestrant
SERD
Cancerology / Radiation oncology / solid tumors
Other
Ki67
ctDNA
Recruiment partially open
Last modification : 2024/05/08
Experimental drug

Phase III


Target population

Medical condition (targeted specialty)

Therapeutic area choices

Cancerology / Radiation oncology / solid tumors

Cancer stages

Other :

Adjuvant

Biomarker

Other :

Ki67

ctDNA

Participants profils

Participants gender(s)

Subjects aptitude

Selection criterias

Inclusion criteria

≥ 18 ans, Cancer du sein invasif précoce, ER+/HER2-, en absence de preuves de stade avancé, ­Thérapie locorégionale adéquate terminée (chirurgie avec ou sans radiothérapie) des tumeurs primaires du sein, avec ou sans thérapie systémique adjuvante, Traitement de thérapie adjuvante endocrine ≥ 2 ans et < 5 ans (+3 mois) en continue

Exclusion criteria

Patients atteints d'un cancer du sein localement avancé inopérable,


Proposed Therapy or Intervention

Intervention

camizestrant

Cohorts
Centre intégré universitaire de santé et de services sociaux du Saguenay–Lac-Saint-Jean
Data not available
Current data since : May 17, 2024 00:15
Centre intégré de santé et de services sociaux des Laurentides
Data not available
Current data since : May 08, 2024 00:16
Centre intégré de santé et de services sociaux de la Montérégie-Centre
Data not available
Current data since : May 13, 2024 00:24
Centre hospitalier de l'Université de Montréal
Data not available
Current data since : April 16, 2024 12:37
Centre intégré universitaire de santé et de services sociaux de l'Est-de-l'Île-de-Montréal
Data not available
Current data since : April 23, 2024 16:14
Centre universitaire de santé McGill
Data not available
Current data since : February 19, 2024 00:31
other centers
Name Medical condition Treatment Recruitment status
Arm A: standard endocrine therapy of investigator´s choice Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) Data not available
  • Unknown
  • Arm B: camizestrant Camizestrant Data not available
  • Unknown
  • Arm A: standard endocrine therapy of investigator´s choice
    Recruitment status
    unknown
    Arm B: camizestrant
    Recruitment status
    unknown
    Current data since : April 18, 2024 20:00

    Study description

    Study summary

    This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

    This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).

    Patients will be followed for 10 years from randomization of the last patient.


    Locations

    Main center

    CENTRE INTÉGRÉ DE SANTÉ ET DE SERVICES SOCIAUX DES LAURENTIDES

    Saint-jérôme

    QUEBEC, CANADA

    Local recruitment
    Recruiting status: UPCOMING

    Participating centers

      10 shown out of 563 centers
    • CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL

      Montréal

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: POSSIBLY OPEN
      Contact details for recruitment
      Local project contacts
      researchers:
      • E. Patocskai

      co-researchers:
      • J. Ayoub

      • S. Hassan

      • R. Younan

      • D. Charpentier

      • K. Boulva

    • CENTRE INTÉGRÉ DE SANTÉ ET DE SERVICES SOCIAUX DE LA MONTÉRÉGIE-CENTRE

      Greenfield park

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: POSSIBLY OPEN
      Local project contacts
      researchers:
      • S. Martel

      co-researchers:
      • G. Speranza

      • C. Prady

      • A. Desnoyers

    • CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DE L'EST-DE-L'ÎLE-DE-MONTRÉAL

      Montréal

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: POSSIBLY OPEN
      Local project contacts
      researchers:
      • J. Noujaim

      • J. NOUJAIM

      co-researchers:
      • M. Gervais

      • L. Sideris

      • M. Soucisse

    • CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DU SAGUENAY–LAC-SAINT-JEAN

      Chicoutimi

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: UPCOMING
    • CENTRE UNIVERSITAIRE DE SANTÉ MCGILL

      Montréal

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: POSSIBLY OPEN
      Local project contacts
      researchers:
      • M. Thirlwell

      co-researchers:
      • S. Soldera

      • J. Asselah

      • N. Bouganim

      • . Mihalcioiu

    • CLINICAL RESEARCH SITE

      Granada

      SPAIN

      Local recruitment
      Recruiting status: UPCOMING
    • FURIEX RESEARCH SITE

      Winter haven

      FLORIDA, UNITED STATES

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      Data not available
    • FURIEX RESEARCH SITE

      Ogden

      UTAH, UNITED STATES

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      Data not available
    • FURIEX RESEARCH SITE

      Corona

      CALIFORNIA, UNITED STATES

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      Data not available
    • FURIEX RESEARCH SITE

      Lynchburg

      VIRGINIA, UNITED STATES

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      Data not available

    Last modification : May 08, 2024
    Current data since : less than a minute
    Data source : Nagano
    Nagano reference: MP-28-2024-171
    ClinicalTrials reference: NCT05774951