Randomized phase 2 study comparing maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab.

Phase 2

• Conditions: Breast cancer

• Registration Number: JPRN-UMIN000008955
• Lead Sponsor: CAPTURE Clinical Trial Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-24
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

1)Prior treatment of bevacizumab 2)Allergy to paclitaxel 3)Brain metastasis with risk of bleeding 4)Pregnancy, nursing 5)Active hepatitis 6)Non-healing severe wound or traumatic bone fracture 7)Pleural effusion, ascites or pericardial effusion that requires drainage 8)Uncontrollable hypertension 9)Usage of antithrombotic agents 10)Continuous administration of corticosteroid 11)Symptomatic congestive heart failure, unstable angina, arrhythmia requiring treatment, myocardial infarction within 1 year 12)Idiopathic pulmonary fibrosis or interstitial pneumonitis 13)Symptomatic cerebral vascular disturbance, or its history within 1 year 14)Deep venous thrombosis or pulmonary infarction, or its history within 1 year 15)Perforation of digestive tract, or its history within 1 year 16)Plan of surgery with risk of bleeding Double cancer within 5 years of disease free interval 17)Symptomatic dysfunctional peripheral neuropathy 18)Active peptic ulcer 19)Body temperature more than 38C

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival between randomization and first progression

Secondary Outcome Measures

Name	Time	Method
Progression free survival between randomization and second progression Progression free survival between first registration and first progression Progression free survival between first registration and second progression Response rate of induction treatment Response rate of second treatment Overall survival since randomization Overall survival since first registration Safety Health Related QOL The related study defines as below in the another protocol Feasibility of biopsy Alteration of immunohistochemistry between primary and metastatic tumor Exploratory immunohistochemistry Whole exon sequencing of genome