JPRN-UMIN000007576已完成2 期
Investigation of Dual-HER2 Blockage Therapy in HER2-Positive Breast Cancer (exploratory randomized P-II)( JBCRG-16 NeoLath) - JBCRG-16(Neo-LaTH)
Japan Breast Cancer Research Group(JBCRG)0 个研究点目标入组 246 人开始时间: 2012年3月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
研究概览
简要总结
Poster:14th St.Gallen Breast Cancer Conference(2015) Symposia:The 23rd Annual Meeting of the Japanese Breast Cancer Society(2015)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •(1)History or drug hypersensitivity that is relevant for the treatment in the study (i.e., past history of immediate or delayed hypersensitivity reaction to compounds chemically similar to lapatinib and its excipients) (2)Uncontrolled concurrent disease (3)Active infection, or pyrexia that indicates suspected infection (4)Symptoms of varicella (5)Pleural or pericardial effusion requiring treatment (6)Past gastric or small bowel resection, or malabsorption or gastrointestinal dysfunction, except for ulcerative colitis (7)Use of concomitant medication (e.g, CYP3A4 inhibitors/inducers) or non-drug therapy prohibited (8)Current chronic use of systemic corticosteroids; in ER-positive patients, current treatment with any drug product containing estrogen or any selective estrogen receptor modulator (9)Dementia or past history of serious psychiatric disease or current treatment for such a disease (10)Bilateral breast cancer whether synchronous or metachronous. Patients who had lobular carcinoma in situ [LCIS] in the contralateral breast may be enrolled. (11)Patients with multiple cancer except for adequately treated noninvasive cancer (DCIS/LCIS), nonmelanoma skin cancer, cervical cancer, thyroid cancer, early gastric cancer and early colorectal cancer. Lesions consistent with carcinoma in situ or intramucosal carcinoma that have been considered cured by local treatment are not included in multiple cancer. (12)Prior treatment with taxane anticancer drugs (13)Pregnant, lactating or women of childbearing potential (14)Participation in another clinical trial (15)Patients otherwise considered ineligible for enrollment in the study by the investigator
研究者
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