A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 510
- 试验地点
- 466
- 主要终点
- Dose-Selection Part: Incidence of dose reduction
研究概览
简要总结
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
详细描述
This is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the safety and efficacy of palazestrant (OP-1250) as a single agent to the standard of care endocrine therapy: either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane).
This trial is seeking adult participants with ER+, HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer. Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 4/6 inhibitor. In the dose-selection part of the trial, approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy. Thereafter, approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy.
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 —（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 or bone-only disease).
- •Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.
- •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
- •Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.
- •Previously received chemotherapy in the advanced/metastatic setting.
- •Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
- •History of allergic reactions to study treatment.
- •Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.
- •Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
- •Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.
研究组 & 干预措施
Palazestrant (OP-1250)
Participants will receive Palazestrant
干预措施: Palazestrant (Drug)
Standard of Care Endocrine Therapy
Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
干预措施: Fulvestrant (Drug)
Standard of Care Endocrine Therapy
Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
干预措施: Letrozole (Drug)
Standard of Care Endocrine Therapy
Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
干预措施: Anastrozole (Drug)
Standard of Care Endocrine Therapy
Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
干预措施: Exemestane (Drug)
结局指标
主要结局
Dose-Selection Part: Incidence of dose reduction
时间窗: From Date of Randomization up to 16 weeks
To evaluate the number of participants reducing the dose of palazestrant
Dose-Selection Part: Incidence of drug discontinuation
时间窗: From Date of Randomization up to 16 weeks
To evaluate the number of participants discontinuing palazestrant
Trial: Progression-Free Survival (PFS)
时间窗: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years)
To compare PFS, based on a Blinded Independent Review Committee (BIRC) assessment, between arms of OP-1250 and standard-of-care treatment. This will be assessed separately in populations of ESR1-mutation detected and ESR1-mutation not detected participants.
Dose-Selection Part: Incidence of adverse events
时间窗: From Date of Randomization up to 16 weeks
To evaluate the number of participants with adverse events
次要结局
- Trial: Overall Survival (OS)(From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years))