Weekly paclitaxel in combination with bevacizumab in patient with HER2 nagative breast cancer who were previously treated with taxane - PhaseII -

UMIN ID: UMIN000009582

Registered date:19/12/2012

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: HER2 negative breast cancer
• Date of first enrollment: 2012/12/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Bavacizumab 10 mg/m2 and Paclitaxel 90 mg/m2

Outcome(s)

• Primary Outcome: Objective response rate
• Secondary Outcome: Progression free survival, Overall survival, Time to treatment failure, Clinical benefit rate, Efficacy analysis by taxane, Safety profile

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 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) Symptomatic brain metastasis 4) Women who is pregnant, lactating or declined contraception 5) Patients with a non-healing wound or fracture 6) Uncontrolled hypertension (SBP>150 mmHg, DBP>100 mmHg) 7) Patients receiving anticoagulant therapy within 10 days prior to registration (aspirin <=325 mg/day is allowed.), or patients need anticoagulant therapy during study 8) Symptomatic congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction within 12 months prior to study entry 9) Idiopathic pulmonary fibrosis, interstitial lung disease 10) Baseline left ventricular ejection fraction (LVEF) > 50% measured by echocardiography 11) Current or previous history (within 12 months) of symptomatic cerebrovascular disease 12) Current or previous history (within 12 months) of deep vein thrombosis or pulmonary embolism 13) Current or previous history (within 12 months) of GI perforation 14) Synchronous or metachronous tumors with <5 years disease-free period 15) Patients ineligible to the study based on decision of attending physician or site principal investigators

Related Information

• Primary Sponsor: Setouchi Breast Project Comprehensive Support Organization
• Source(s) of Monetary Support: Setouchi Breast Project Comprehensive Support Organization