JPRN-jRCT2080224052已完成3 期
A PHASE III, RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
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
- •Patients with Stage II-IIIC, locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer
- •- Primary tumor > 2 cm in diameter, or node-positive
- •- HER2-positive breast cancer confirmed by a central laboratory
- •- Hormone receptor status of the primary tumor, centrally confirmed
- •- Patients who can use method of contraception certainly (Women of childbearing potential must have a negative serum pregnancy test result)
排除标准
- •- Patients with a history of invasive breast cancer
- •- Patients with multicentric breast cancer, unless all tumors are HER2-positive
- •- Patients with bilateral breast cancer
- •- Patients with serious cardiac illness or medical conditions
- •- Patients with known active liver disease or known infection with HIV
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