JPRN-jRCT2080224945已完成3 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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 contraceptive methods, 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 (RECIST v1.1).
- •-Phase III only: Tumor specimen from the most recently collected, available tumor tissue..
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 III only: Prior treatment with CDK4/6 inhibitor for locally advanced unresectable or metastatic breast cancer.
- •-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.
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