EUCTR2012-003065-17-ES进行中（未招募）1 期
An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer - BOLERO-4
ovartis Farmacéutica S.A.0 个研究点目标入组 202 人开始时间: 2013年4月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •?Patients 18 years old or greater
- •?Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
- •?Histological or cytological confirmation of estrogen-receptor positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- •?Postmenopausal women
- •?No prior treatment for metastatic breast cancer
- •Other protocol based inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 142
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 87
排除标准
- •?Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
- •?Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
- •?Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
- •?Previous treatment with mTOR inhibitors.
- •?Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
- •?Other protocol-defined inclusion/exclusion criteria may apply
- •Other protocol based exclusion criteria may apply
研究者
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