A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

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.

Trial Details

NCT ID
NCT05774951
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Camizestrant
  • Tamoxifen
  • Anastrozole
  • Letrozole
  • Exemestane
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Dothan, Alabama, United States|31.22323,-85.39049
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Hot Springs, Arkansas, United States|34.5037,-93.05518

Key Eligibility Criteria

  • Women and Men, ≥18 years at the time of screening (or per national guidelines)
  • Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-path…
  • Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)…
  • Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)

For full eligibility, visit ClinicalTrials.gov.

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