EUCTR2008-008698-69-BE进行中（未招募）不适用
A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination with Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer who are refractory to Letrozole or Anastrozole.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 705
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
- •Adult women (= 18 years of age) with metastatic or locally advanced
- •breast cancer not amenable to curative treatment by surgery or radiotherapy.
- •Histological or cytological confirmation of estrogen-receptor positive
- •(ER+) breast cancer
- •Postmenopausal women.
- •Disease refractory to non steroidal aromatase inhibitors (NSAI),
- •Radiological or objective evidence of recurrence or progression on or after the last systemic
- •therapy prior to randomization.
- •Patients must have at least one lesion that can be accurately measured or bone lesions in the
- •absence of measurable disease
- •Adequate bone marrow and coagulation function
- •XML File Identifier: 3jczDLR0oQk0bMFqm2gcEjpmbt4=
- •Adequate liver and renal function
- •ECOG Performance Status = 2 or less
- •Other protocol-defined 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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 305
排除标准
- •HER2-overexpressing patients
- •Patients with only non-measurable lesions other than bone metastasis
- •(e.g. pleural effusion, ascites etc.).
- •Patients who received more than one chemotherapy line for Advanced
- •Breast Cancer.
- •Previous treatment with exemestane or mTOR inhibitors.
- •Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
- •Radiotherapy within four weeks prior to randomization
- •Currently receiving hormone replacement therapy,
- •Patients receiving immunosuppressive agents or chronic corticosteroids use
- •Patients being treated with strong inhibitors or inducers of CYP3A
- •within 5 days prior to randomization
- •Other protocol-defined exclusion criteria may apply
研究者
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