EUCTR2010-023763-17-HU
进行中（未招募）
1 期
A phase II double-blind placebo-controlled randomized study of GDC-0941 or GDC-0980 with Fulvestrant versus Fulvestrant in advanced or metastatic breast cancer in patients resistant to aromatase inhibitortherapy
适应症Advanced or metastatic breast cancer resistant to aromatase inhibitor therapyMedDRA version: 14.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
相关药物Faslodex
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Advanced or metastatic breast cancer resistant to aromatase inhibitor therapy
- 发起方
- Genentech, Inc.
- 入组人数
- 350
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Age \= 18 years
- •2\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •3\. Postmenopausal women with locally advanced breast cancer or MBC whose disease relapsed during treatment with (or within 6 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting. The AI must be most
- •recent treatment prior to enrollment and patients must have received at least 4 weeks of treatment with an AI prior to recurrence or disease progression.
- •4\. ER\-positive disease and HER2\-negative disease
- •5\. Measurable disease or non\-measurable disease
- •6\. Adequate hematologic and end\-organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
排除标准
- •1\. Prior treatment with fulvestrant, PI3K inhibitor, or mTOR inhibitor for advanced breast cancer or MBC
- •2\. Prior anti\-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
- •3\. Prior treatment with \> 1 cytotoxic chemotherapy regimens or \> 2 endocrine therapies for MBC
- •4\. Patients requiring anti\-hyperglycemic therapy
- •5\. History of clinically significant cardiac or pulmonary dysfunction
- •6\. Clinically significant history of liver disease, including cirrhosis,
- •current alcohol abuse, or current known active infection with hepatitis B virus, or hepatitis C virus
- •7\. Need for current chronic corticosteroid therapy
- •8\. Known untreated or active CNS metastases
结局指标
主要结局
未指定
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