A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 198
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
详细描述
This is an international, multicenter, randomized, double-blind, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the efficacy and safety of palazestrant in combination with ribociclib +letrozole -matching placebo (Arm A: investigational arm) with letrozole in combination with ribociclib + palazestrant-matching placebo (Arm B: control arm).
This trial is seeking adult participants with ER+, HER2- advanced breast cancer who have not received prior systemic anti-cancer treatment for advanced disease. Approximately 1,000 participants will be randomized in a 1:1 ratio to one of the two study arms.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult female or male participants.
- •ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- •Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
- •De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate hematologic, hepatic, and renal functions.
- •Female participants can be pre-, peri- or postmenopausal.
- •Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
排除标准
- •Disease recurrence during adjuvant endocrine therapy
- •Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
- •Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
- •History of allergic reactions to study treatment.
- •Any contraindications to letrozole and ribociclib.
- •Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
研究组 & 干预措施
Letrozole
Participants will receive letrozole, ribociclib and palazestrant-matching placebo
干预措施: Palazestrant matching-placebo (Drug)
Palazestrant
Participants will receive palazestrant, ribociclib and letrozole-matching placebo
干预措施: Letrozole-matching placebo (Drug)
Palazestrant
Participants will receive palazestrant, ribociclib and letrozole-matching placebo
干预措施: Ribociclib (Drug)
Letrozole
Participants will receive letrozole, ribociclib and palazestrant-matching placebo
干预措施: Letrozole (Drug)
Letrozole
Participants will receive letrozole, ribociclib and palazestrant-matching placebo
干预措施: Ribociclib (Drug)
Palazestrant
Participants will receive palazestrant, ribociclib and letrozole-matching placebo
干预措施: Palazestrant (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)
To compare PFS, based on a local investigator assessment, between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.
次要结局
- Progression Free Survival (PFS)(From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years))
- Safety and tolerability(Up to 42 days after end of treatment (estimated as up to 3.5 years))
- Overall Survival (OS)(From Date of Randomization until Death Due to Any Cause (estimated as up to 5.5 years))
- Pharmacokinetics (PK) of palazestrant and ribociclib(Every 28 days (estimated as up to 3.5 years))
- Health-related patient-reported outcomes (PROs)(Every 28 days (estimated as up to 3.5 years))
- Overall response Rate (ORR)(From Date of Randomization until Tumor Response (estimated as up to 3.5 years))
- Duration of Response (DOR)(From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years))
- Clinical Benefit Rate (CBR)(Proportion of subjects achieving CR, PR or SD with duration of at least 24 weeks (estimated as up to 3.5 years))