NL-OMON40248已完成不适用
1280.4: A Phase Ib/II Randomized Study of BI 836845 in Combination with Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women with Locally Advanced or Metastatic Breast Cancer - 1280.4
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically-confirmed locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
- •- Tumors are positive for estrogen-receptor (ER) and/or progesterone receptor (PgR). Tumors must be negative for HER2 per local lab testing.
- •- Postmenopausal women
- •- Objective evidence of recurrence or progression on or after the last systemic therapy prior to the study entry
- •- Disease refractory to non-steroidal aromatase inhibitors (letrozole and/or anastrozole)
- •- ECOG<<=2
- •- Patients must have a measurable lesion according to RECIST version 1.1 or bone
- •lesion only: lytic or mixed (lytic + sclerotic) in the absence of measurable lesions
排除标准
- •-Previous treatment with agents targeting on IGF pathway, PI3K signaling pathway, protein kinase B (AKT), or mTOR pathways (sirolimus, temsirolimus, etc.)
- •-Prior treatment with exemestane
- •-History of another primary malignancy within 5 years, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
研究者
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