A Study of Camizestrant in ER+/​HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy (CAMBRIA-1)

NCT 05774951

 

Brief 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.

Intervention / Treatment 

  • DrugCamizestrant
  • DrugTamoxifen
  • DrugAnastrozole
  • DrugLetrozole
  • DrugExemestane

Inclusion 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-pathological risk features, as defined in the protocol.
  • Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
  • Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Adequate organ and marrow function.

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