JPRN-jRCT1080222272已完成4 期
A post-marketing clinical study to evaluate the efficacy and safety of pertuzumab combined with trastuzumab and docetaxel as first line treatment in HER2- positive inoperable or recurrent breast cancer
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
研究概览
简要总结
The efficacy and safety of P+T+D in Japanese patients were consistent with those of the CLEOPATRA study and we confirmed this treatment as a standard care at 1st line therapy for HER2-positive metastatic breast cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •HER2 positive (IHC 3+ or ISH-positive)
- •- cancer of the breast, with inoperable or recurrent disease, and candidate for chemotherapy
- •- ECOG performance status 0 or 1.
排除标准
- •- History of anticancer therapy (any EGFR or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen) for inoperable or recurrent breast cancer.
- •- History of tyrosine kinase/HER family inhibitors for breast cancer, except trastuzumab used in the neoadjuvant or adjuvant setting
- •- History of systemic breast cancer treatment in the neoadjuvant or adjuvant setting with a disease-free interval from completion of the taxane in the neoadjuvant or adjuvant setting to recurrent diagnosis of < 12 months
- •- CNS metastases
- •- Clinically relevant cardiovascular disease
研究者
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