NCT06492616招募中3 期
Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4,220
- 试验地点
- 1,055
- 主要终点
- Invasive Breast Cancer-Free Survival (IBCFS)
研究概览
简要总结
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
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
- •Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry [IHC]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization [ISH]-negative [not amplified]). ISH-negative without IHC testing will also be eligible on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists guidelines.
- •Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria:
- •≥4 positive axillary lymph nodes or
- •1-3 positive axillary lymph nodes and
- •Histologic grade 3 disease and/or
- •Tumor size ≥5 centimeters and/or
- •High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50)
- •Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 [C1D1]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist.
- •Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase inhibitor must have already completed or discontinued these treatments.
排除标准
- •Participants with inflammatory breast cancer.
- •History of any prior (ipsilateral and/or contralateral) invasive breast cancer.
- •Participant with history of non-breast malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
- •Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Elacestrant
Experimental
Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years.
干预措施: Elacestrant (Drug)
Standard of Care (SoC) Endocrine Therapy
Experimental
Participants will receive the SoC endocrine therapy that was used prior to randomization:
- AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or
- Tamoxifen 20 mg QD
干预措施: Anastrozole (Drug)
Standard of Care (SoC) Endocrine Therapy
Experimental
Participants will receive the SoC endocrine therapy that was used prior to randomization:
- AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or
- Tamoxifen 20 mg QD
干预措施: Tamoxifen (Drug)
Standard of Care (SoC) Endocrine Therapy
Experimental
Participants will receive the SoC endocrine therapy that was used prior to randomization:
- AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or
- Tamoxifen 20 mg QD
干预措施: Exemestane (Drug)
Standard of Care (SoC) Endocrine Therapy
Experimental
Participants will receive the SoC endocrine therapy that was used prior to randomization:
- AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or
- Tamoxifen 20 mg QD
干预措施: Letrozole (Drug)
结局指标
主要结局
Invasive Breast Cancer-Free Survival (IBCFS)
时间窗: Up to 5 years
Assessed by the time from date of randomization to the date of first occurrence of: * Ipsilateral invasive breast tumor recurrence * Local/regional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer, or * Death attributable to any cause
次要结局
- Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5)
- Distant Relapse-Free Survival (DRFS)(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30(Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5)
- Invasive Disease-Free Survival (IDFS)(Up to 5 years)
- Number of Participants With Adverse Events (AEs)(Up to 5 years plus 28 days)
- Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42)(Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5)
- Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)(Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5)
- Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant(Predose up to 4 hours postdose)
- Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant(Predose up to 4 hours postdose)
研究者
研究点 (1055)
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