JPRN-UMIN000008662已完成2 期
A Randomized Phase II Study of Maintenance Hormone Therapy with or without Capecitabine after Induction Chemotherapy with Bevacizumab plus Paclitaxel in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer (KBCSG-TR1214) - A Randomized Phase II Study of Maintenance Hormone Therapy with or without Capecitabine after Induction Chemotherapy with Bevacizumab plus Paclitaxel in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer (KBCSG-TR1214)
KBCSG-TR(Kinki Breast Cancer Study Group-TR)0 个研究点目标入组 120 人开始时间: 2012年8月9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
- 120
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
- 20years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •(1)Prior therapy with bevacizumab (2)Hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, chinese hamster ovary cell derived products or other recombinant humanized antibodies (3)Hypersensitivity to capecitabine or fluoropyrimidines (4)Clinically or radiographically confirmed brain metastases (5)Treated brain metastasis within 3 months prior to registration (6)Women who is pregnant, lactating or declined contraception (7)Obvious infection or inflammation (with fever >= degrees centigrade (8)Active hepatitis (9)Patients with a nonhealing wound or fracture. (10)Massive pleural effusion, ascites or cardiac effusion (11)Uncontrolled hypertension (SBP>150 mmHg, DBP>100 mmHg). (12)Patients receiving anticoagulant therapy within 10 days prior to registration (aspirin <=325 mg/day is allowed.), or patients need anticoagulant therapy during study (13)Under coutinuous corticosteroid administration. (14)Symptomatic congestive heart failure,unstable angina, uncontrolled arrhythmia, myocardial infarction within 12 months prior to study entry. (15)Idiopathic pulmonary fibrosis, interstitial lung disease (16)Current or previous history (within 12 months) of symptomatic cerebrovascular disease (17)Current or previous history (within 12 months) of deep vein thrombosis or pulmonary embolism. (18)Current or previous history (within 12 months) of GI perforation (19)Active peptic ulcer (20)Planned surgery within study term (21)Synchronous or metachronous tumors with <5 years disease-free period (22)Symptomtic peripheral neuropathy with functional disorders. (23)Patients ineligible to the study based on decision of attending physician or site principal investigators.
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