EUCTR2010-023763-17-DK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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
- •1. Age = 18 years
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •3. Postmenopausal women with locally advanced breast cancer previously treated with an aromatase inhibitor (AI)
- •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
- •F.1.2.1 Number of subjects for this age range 143
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 117
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 experienced recurrent or progressive disease on > 2 endocrine therapies for MBC
- •4. Patients requiring anti-hyperglycemic therapy
- •5. 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
研究者
相似试验
进行中（未招募）
1 期
Study of the novel cancer drug GDC-0941 in combination with the approved anticancer drug fulvestrant, and the novel cancer drug GDC-0980 in combination with fulvestrant, in patients with advanced breast cancer for whom treatment with an aromatase inhibitor is not effectiveAdvanced or metastatic breast cancer resistant to aromatase inhibitor therapyMedDRA version: 17.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864EUCTR2010-023763-17-DEGenentech, Inc.260
进行中（未招募）
1 期
Study of the novel cancer drug GDC-0941 in combination with the approved anticancer drug fulvestrant, and the novel cancer drug GDC-0980 in combination with fulvestrant, in patients with advanced breast cancer for whom treatment with an aromatase inhibitor is not effectiveAdvanced 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)EUCTR2010-023763-17-HUGenentech, Inc.350
进行中（未招募）
1 期
Study of the novel cancer drug GDC-0941 in combination with the approved anticancer drug fulvestrant, and the novel cancer drug GDC-0980 in combination with fulvestrant, in patients with advanced breast cancer for whom treatment with an aromatase inhibitor is not effectiveAdvanced or metastatic breast cancer resistant to aromatase inhibitor therapyMedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864EUCTR2010-023763-17-BEGenentech, Inc.260
进行中（未招募）
不适用
Study of the novel cancer drug GDC-0941 in combination with the approved anticancer drug fulvestrant, and the novel cancer drug GDC- 0980 in combination with fulvestrant, in patients with advanced breast cancer for whom treatment with an aromatase inhibitor is not effectiveAdvanced or metastatic breast cancer resistant to aromatase inhibitortherapy.MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023763-17-ITROCHE350
进行中（未招募）
不适用
Study of the novel cancer drug GDC-0941 in combination with the approved anticancer drug fulvestrant, and the novel cancer drug GDC-0980 in combination with fulvestrant, in patients with advanced breast cancer for whom treatment with an aromatase inhibitor is not effectiveEUCTR2010-023763-17-GBGenentech, Inc.260