Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 478
- 试验地点
- 244
- 主要终点
- Progression-free Survival in ESR1-mut Participants
研究概览
简要总结
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI).
详细描述
This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in participants with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut participants) or in all participants regardless of ESR1 status (ESR1-mut and ESR1 wild type [ESR1-wt]) and whose disease has relapsed or progressed on at least one and no more than two prior lines of endocrine therapy (with documented progression), which must have included prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI) and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole, letrozole, exemestane) is an appropriate treatment option.
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
- •Participants with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy.
- •Participants must be appropriate candidates for endocrine monotherapy
- •Participants must have measurable disease or bone only disease with evaluable lesions
- •Female or male participants age ≥ 18 years; female participants must be postmenopausal women, and male participants must not allow pregnancy with their sperm (abstain, do not donate sperm, et cetera).
- •Participants must have ER+ and HER2- tumor status
- •Participants must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria.
- •Participants must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI) for advanced/metastatic breast cancer (mBC).
- •Participants may have received no more than one line of chemotherapy in the advanced/metastatic setting.
排除标准
- •Prior treatment with elacestrant or other investigational selective estrogen receptor degrader (SERD) or ER antagonist (D-0502, GDC-0810, GDC-0927, GDC-9545, G1T-48, LSZ102, AZD9496, SAR439859, ZN-c5, H3B-6545, bazedoxifene, lasofoxifene).
- •Prior anticancer or investigational drug treatment within the following windows:
- •Fulvestrant treatment < 42 days before first dose of study drug
- •Any endocrine therapy < 14 days before first dose of study drug
- •Chemotherapy < 21 days before first dose of study drug
- •Any investigational anti-cancer drug therapy < 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of participants whose most recent therapy was an investigational agent should be discussed with the Sponsor
- •Bisphosphonates or RANKL inhibitors initiated or dose changed < 3 months prior to first dose of study drug
- •Presence of symptomatic visceral disease as defined in protocol.
研究组 & 干预措施
Elacestrant
Participants in Arm 1 will receive elacestrant.
干预措施: Elacestrant (Drug)
Standard of Care (SoC)
Participants in Arm 2 will receive investigator's choice of one of the standard-of-care drugs (fulvestrant, anastrozole, letrozole, or exemestane).
干预措施: Standard of Care (Drug)
结局指标
主要结局
Progression-free Survival in ESR1-mut Participants
时间窗: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Progression-free survival based on blinded IRC assessment in ESR1-mut participants defined as the length of time from randomization until the date of objective disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by the blinded IRC or death from any cause. Progression is defined per RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Progression-free Survival in All Participants
时间窗: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Progression-free survival based on blinded imaging review committee (IRC) assessment in all (ESR1-mut and ESR1-wt) participants.
次要结局
- Overall Survival in ESR1-mut Participants(From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months))
- Overall Survival in All Participants(From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months))