Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Phase 2
- Conditions
- Primary breast cancer
- Registration Number
- JPRN-UMIN000001205
- Lead Sponsor
- Saitama Breast Cancer Clinical Study Group (SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 63
Inclusion Criteria
Not provided
Exclusion Criteria
1)Severe complication 2)Inflammatory breast caner and male breast cancer 3)Ischemic heart disease or arrhythmia which needs medical treatment (history of myocardial infarction occured within 6 months) 4)Uncontrolled diabetes 5)Suspicious of infection 6)History of serious hypersensitivity or history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate 7)During pregnancy or lactation 8)Patient judged inappropriate by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response; pCR rate
- Secondary Outcome Measures
Name Time Method Clinical response rate Disease free survival Overall survival Breast conserving rate Treatment compliance Biomarkers