2025-522873-12-00招募中3 期
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)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 42
- 主要终点
- Local Investigator-assessed PFS (Progression-Free Survival)
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Local Investigator-assessed PFS (Progression-Free Survival)
Local Investigator-assessed PFS (Progression-Free Survival)
次要结局
- 1. OS
- 2. BIRC-assessed PFS, ORR, DOR and CBR
- 3. Local Investigator-assessed ORR, DOR, CBR
- 4. Safety and tolerability, assessed by AEs, SAEs, dose modifications, clinical laboratory parameters, ECGs, performance status, and vital sign measurements
- 5. Plasma levels of palazestrant and ribociclib (in investigational arm) and of ribociclib (in control arm) at predefined intervals to establish PK parameters.
- 6. PRO endpoints, assessed using the EORTC QLQ- C30, EORTC QLQ-BR42 and EQ-5D-5L questionnaires
- 7. Time from randomization to disease progression on first subsequent systemic anti-cancer therapy or death
研究者
Olema Pharmaceuticals
Scientific
Olema Pharmaceuticals Inc.
研究点 (42)
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