CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
AstraZeneca
Summary
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
Description
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the…
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
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 absence of any evidence of metastatic disease 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. * Patients must be randomised within 12 months of definitive breast surgery. * Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.…
Interventions
- DrugCamizestrant
Camizestrant. Experimental. Administered orally
- DrugTamoxifen
Tamoxifen. Comparator. Administered orally
- DrugAnastrozole
Anastrozole. Comparator. Administered orally
- DrugLetrozole
Letrozole. Comparator. Administered orally
- DrugExemestane
Exemestane. Comparator. Administered orally
- DrugAbemaciclib
Abemaciclib adjuvant treatment Administered orally
Locations (794)
- Research SiteDothan, Alabama
- Research SitePhoenix, Arizona
- Research SiteTucson, Arizona
- Research SiteFayetteville, Arkansas
- Research SiteDuarte, California
- Research SiteFountain Valley, California