NCT07766018招募中2 期
A Phase 2 Open-Label, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Elacestrant Monotherapy for the Treatment of Japanese Participants With ER+/HER2- Advanced or Metastatic Breast Cancer With ESR1-mutation Following CDK4/6 Inhibitor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 11
- 主要终点
- Progression-free Survival as Assessed by the Imaging Review Committee
研究概览
简要总结
This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in combination with fulvestrant or an aromatase inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Must have a histologically or cytologically 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
- •Female participants must be post-menopausal (as defined by the protocol)
- •Must have ER+ and HER2- tumor status confirmed per local laboratory testing
- •Participants must be ESR1-mutant positive determined via testing with the Guardant360 Companion Diagnostic panel test prior to enrollment
- •Must have disease progression during or within 28 days of completion of prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (this counts as a line of prior endocrine therapy) for metastatic breast cancer
排除标准
- •Prior treatment with: elacestrant or investigational or approved selective estrogen receptor degrader or ER antagonist; antibody-drug conjugate therapy for advanced/metastatic breast cancer; anti-cancer or investigational drug treatment
- •Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug
- •Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion)
- •Diagnosis of any other malignancy within 5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or second primary breast cancer
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Elacestrant
Experimental
Participants will receive elacestrant once daily.
干预措施: Elacestrant (Drug)
结局指标
主要结局
Progression-free Survival as Assessed by the Imaging Review Committee
时间窗: Up to approximately 27 months
次要结局
- Overall Survival(Up to approximately 27 months)
- Number of Participants with Adverse Events(Up to approximately 27 months)
- Plasma Concentration of Elacestrant(Up to approximately 27 months)
- Progression-free Survival as Assessed by the Investigator(Up to approximately 27 months)
研究者
研究点 (11)
Loading locations...
相似试验
尚未招募
3 期
A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)NCT07621601Hansoh BioMedical R&D Company494
尚未招募
3 期
A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic AlterationsNon-Small Cell Lung CancerNCT07464327Hansoh BioMedical R&D Company450
尚未招募
1 期
A Phase I/II Study of Eque-cel in Subjects Withimmune-mediated Necrotizing MyopathyRefractory Immune-mediated Necrotizing MyopathyNCT07752264Nanjing IASO Biotechnology Co., Ltd.27
尚未招募
3 期
A Prospective, Multicenter, Phase III Clinical Evaluation of the Safety and Efficacy of NH002 as a Contrast Agent Administrated Via Intravenous Bolus Injection and Infusion for Subjects Undergoing Cardiac EchocardiographyCardiac DiseasesNCT07740421Trust Bio-sonics, Inc.150
已完成
2 期
A Phase IIa Study in Primary IgA Nephropathy PatientsNCT07634744S-INFINITY Pharmaceuticals Co., Ltd25