2024-519792-25-00招募中2 期
Elacestrant and exemestane for patients with pretreated HR+/HER2- metastatic breast cancer and [18F]-FES-avid lesions (COMBINE): a proof-of-concept phase 2 clinical trial
Istituto Europeo Di Oncologia S.r.l.1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年10月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 6-month PFS rate per RECIST v 1.1
研究概览
简要总结
To assess the activity of elacestrant plus exemestane
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Histologically - or cytologically-proven diagnosis of HR+ (Estrogen Receptor: ≥10%)/HER2- carcinoma 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
- •Appropriate candidates for endocrine therapy (no visceral crisis, highly symptomatic disease or rapidly progressing disease)
- •Measurable disease per RECIST or bone only disease with evaluable lesions
- •≥50% of measurable lesions defined as avid (SUVmax≥1.5) at 18F-FES-PET/CT
- •Progressed on prior treatment with a CDK4/6 inhibitor in combination with anastrozole or letrozole (+ LHRH agonist for male or premenopausal female patients), in first line setting for metastatic disease, for at least 12 months and there must have been evidence of disease control (at least stable disease per RECIST v.1.1)
- •ECOG performance status 0 or 1
- •Adequate organ function
排除标准
- •Prior treatment with fulvestrant, elacestrant or investigational SERD or ER antagonist in metastatic or early disease
- •Prior treatment with tamoxifen or SERD alone or combined with CDK4/6i in the metastatic setting
- •Bisphosphonates or RANKL inhibitors initiated or dose changed < 3 months prior to first dose of study drug
- •Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug
- •Presence of symptomatic metastatic visceral disease or meningeal disease
- •Pregnancy at the time of the study entry
- •Diagnosis of inflammatory breast cancer and chest wall disease
结局指标
主要结局
6-month PFS rate per RECIST v 1.1
6-month PFS rate per RECIST v 1.1
次要结局
- Adverse Events per CTCAE 5.0
- Median Overall Survival
- Overall Response Rate per RECIST 1.1
- Median QoL change from baseline to week 8 of treatment measured by EORTC QLQ-C30 and FACT-ES v.4 questionaries
- 6-months Progression-free survival (PFS) rate per RECIST 1.1 according to baseline FES-SUV and SUV variation of FES
研究者
Giuseppe Curigliano
Scientific
Istituto Europeo Di Oncologia S.r.l.
研究点 (1)
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