EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 8,000
- 试验地点
- 1,263
- 主要终点
- Invasive Disease-Free Survival (IDFS)
研究概览
简要总结
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
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
- •Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
- •Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
- •Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
- •Must have an increased risk of disease recurrence based on clinical-pathological risk features.
- •Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
- •Have adequate organ function.
排除标准
- •Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
- •Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
- •Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
- •Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
- •Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
- •Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
- •Participants with a history of any other cancer.
- •Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.
研究组 & 干预措施
Imlunestrant
Imlunestrant administered orally.
干预措施: Imlunestrant (Drug)
Investigator's Choice of Endocrine Therapy
Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.
干预措施: Tamoxifen (Drug)
Investigator's Choice of Endocrine Therapy
Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.
干预措施: Anastrozole (Drug)
Investigator's Choice of Endocrine Therapy
Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.
干预措施: Letrozole (Drug)
Investigator's Choice of Endocrine Therapy
Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.
干预措施: Exemestane (Drug)
结局指标
主要结局
Invasive Disease-Free Survival (IDFS)
时间窗: Randomization to recurrence or death from any cause (up to 10 years)
IDFS excluding second non-breast primary invasive cancers
次要结局
- Distant Recurrence-Free Survival (DRFS)(Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years))
- Overall Survival (OS)(Randomization to Death from Any Cause (up to 10 Years))
- Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant(Year 1, Month 2 to Month 4)
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning(Visit 1 Day 1 up to end of Year 5)
- Change from Baseline in the EORTC QLQ-C30 Global QOL(Visit 1 Day 1 up to end of Year 5)
- Change from Baseline in the EORTC QLQ-C30 Role Functioning(Visit 1 Day 1 up to end of Year 5)
- Proportion of Time on Study Treatment with High Overall Adverse Event Burden(Visit 1 Day 1 up to end of Year 5)