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An Adjuvant Endocrine-Based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer

Primary:
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of invasive breast cancer-free survival (IBCFS).

Secondary:
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of invasive disease-free survival (IDFS).

- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of distant relapse-free survival (DRFS).

- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of overall survival (OS).

- To demonstrate superior tolerability of camizestrant ± abemaciclib as compared to
standard ET ± abemaciclib by assessment of the proportion of time on study treatment with high side-effect burden.

- To assess patient-reported treatment-associated symptoms of arthralgia, hot flush, and vaginal dryness of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib.

- To assess patient-reported health-related QoL in patients treated with camizestrant ± abemaciclib as compared to standard ET ± abemaciclib.

- To assess the steady-state PK of camizestrant in patients who received at least 1 dose of camizestrant per the protocol, for whom there is at least 1 reportable PK concentration.


Safety:
- To assess safety of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib.

Protocol Number: 042312
Phase: Phase III
Applicable Disease Sites: Breast
Drugs Involved: Abemaciclib
ANASTROZOLE
Camizestrant
EXEMESTANE
LETROZOLE
TAMOXIFEN
Principal Investigator: Mridula A George
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Cooperman Barnabas, Livingston
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Somerset
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.