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
- Conditions
- Hormone receptor positive, HER2 negative advanced or recurrence (metastatic) breast cancer
- Registration Number
- JPRN-UMIN000012179
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 160
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method