Phase II clinical study of R435 (bevacizumab) in combination with paclitaxel in patients with inoperable metastatic breast cancer
Phase 2
- Conditions
- Inoperable metastatic breast cancer
- Registration Number
- JPRN-jRCT2080220385
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
at least 20 years old and obtained a written informed consent
- Advanced breast cancer (Stage IV) or Inoperable metastatic breast cancer
- HER2 negative
- At least one measurable lesion based on RECIST criteria
- No previous chemotherapy for metastatic breast cancer
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoints: Safety, Progression-free survival (PFS) Secondary endpoints: Tumor response (Response rate, duration of response, Time to response), Overall survival (OS), Time to treatment failure (TTF)
- Secondary Outcome Measures
Name Time Method