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. - CAMBRIA-2

Hibi Kazushige0 个研究点目标入组 550 人开始时间: 2023年11月11日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•Women and Men; 18 years or more 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 or less
•- Adequate organ and bone marrow function

•- 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 2 or more.
•- 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.

发起方

Hibi Kazushige