EUCTR2019-001072-11-ES进行中（未招募）1 期
A PHASE IB/III STUDY OF IPATASERTIB PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN HORMONE RECEPTOR POSITIVE AND HER2 NEGATIVE LOCALLY ADVANCED UNRESECTABLE OR METASTATIC BREAST CANCER
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd0 个研究点目标入组 370 人开始时间: 2019年7月5日最近更新:
适应症
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
- 370
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
- All
入选标准
- •- Age >= 18 years
- •- HR+ HER2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic
- •- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
- •- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
- •- Radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer
- •- At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1
- •- Phase III only: Tumor specimen from the most recently collected, available tumor tissue
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •- Pregnant or breastfeeding, or intending to become pregnant
- •- Prior treatment with fulvestrant or other selective estrogen receptor down-regulator
- •- Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor
- •- Phase Ib only: Prior treatment with CDK4/6 inhibitor
- •- Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer
- •- History of Type I or Type II diabetes mellitus requiring insulin
- •- History of or active inflammatory bowel disease or active bowel inflammation
- •- Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections
研究者
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