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Breast cancer
CAMBRIA-2
CAMBRIA-2: A Phase III, Randomised, Open-label Study to Evaluate the Efficacy and Safety of Camizestrant (AZD9833), a Next Generation Oral Selective Estrogen Receptor Degrader (ngSERD), Compared with Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment in Patients with Estrogen Receptor-positive, HER2-negative Early Breast Cancer at Medium to High or High Risk of Recurrence, Who Have Completed Definitive Locoregional Therapy and Have No Evidence of Disease.
- Open at Paris since : 13/05/2025
- Open at Saint-Cloud since : 15/10/2025
- Target : Adult
- Phase : Phase III
Trial description
The objective of this Phase III study is to evaluate whether camizestrant can improve invasive breast cancer-free survival (IBCFS) compared to standard adjuvant therapy in patients with early-stage ER+/HER2- breast cancer who are at medium-high or high risk of recurrence, have completed definitive locoregional therapy, and show no evidence of disease.;The currently approved standard endocrine therapy (ET) consists of an aromatase inhibitor (AI) or tamoxifen (with a concomitant luteinizing hormone-releasing hormone [LHRH] agonist in premenopausal and perimenopausal women and men), given for 5 to 10 years.;In some countries, the addition of abemaciclib during the first 2 years of ET is also approved for high-risk patients only.;This study will assess the benefit of camizestrant ¦ abemaciclib versus standard ET (AI or tamoxifen) ¦ abemaciclib, with the concomitant use of an LHRH agonist in premenopausal and perimenopausal women and men, in the adjuvant treatment of early-stage breast cancer.;The planned duration of treatment in either study arm is 7 years (84 months).
Url of the trialMain investigators
