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

AstraZeneca1460 个研究点分布在 2 个国家目标入组 5,511 人开始时间: 2023年10月5日最近更新: 2026年8月10日

适应症

干预措施

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方: AstraZeneca
入组人数: 5,511
试验地点: 1,460
主要终点: Invasive breast cancer-free survival (IBCFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

详细描述

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 study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).

Patients will be followed for 10 years from randomization of the last patient.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 130 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
•Adequate organ and bone marrow function

排除标准

•Inoperable locally advanced or metastatic breast cancer
•Pathological complete response following treatment with neoadjuvant therapy
•History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
•Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
•Known LVEF <50% with heart failure NYHA Grade ≥
•Mean resting QTcF interval > 480 ms at screening
•Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
•Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
•Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
•Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
•Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.