Breast Cancer (CAMBRIA-1)

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

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

Sponsor(s): Astra Zeneca

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
    • Prior adjuvant therapy with CDK4/6 inhibitors for 2 years is allowed
    • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
    • Adequate organ and marrow function

Location(s): Hartford Hospital, HOCC, Midstate and SVMC
Contact(s): Rebecca Gripp 860-972-5371

Cancer Clinical Research Office