Bevacizumab plus paclitaxel optimization study with interventional maintenance endocrine therapy in advanced or metastatic ER-positive HER2-negative breast cancer-BOOSTER trial, a multicenter randomized phase II study - JBCRG-M04 (BOOSTER)

Japan Breast Cancer Research Group (JBCRG)0 个研究点目标入组 160 人开始时间: 2013年10月31日最近更新: 2023年10月17日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 160

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Median TFS (time-to-failure of strategy) are 8.87 months in the wPTX + BV continued group, and 16.82 months in the maintenance endocrine + BV group, respectively (HR 0.51; p<0.001). OS (overall survival) in both groups are similar, which means chemo-holiday with endocrine based therapy could be safely applied to ER+HER2-ABC/MBC after induction chemotherapy. HRQoL seems to be better in endocrine + BV compared to chemotherapy continuous strategy.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 75years-old（—）
性别: Female

入选标准

未提供

排除标准

•(1)Prior therapy with bevacizumab (2) Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV. (3) Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period. (4) Known hypersensitivity to bevacizumab or paclitaxel (5) History of hemoptysis (>= 2.5mL of bright red blood per episord). (6) Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride (7) Patients with CNS metastases (except for not symptomatic) (8) Persistent Grade >= 2 sensory neuropathy at enrollment (9) Grade 3 >= hypertension (>= 2 use of antihypertensive drug) 10) Evidence with arterial thromboembolism (Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment. (11) Evidence withvenous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment. (12) History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment (13) Cases that the investigator judged as inappropriate as the subject of this clinical study

研究者

发起方

Japan Breast Cancer Research Group (JBCRG)

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