Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary breast cancer
- Conditions
- Resectable primary breast cancer
- Registration Number
- JPRN-UMIN000009035
- Lead Sponsor
- PerSeUS:Perpetual Study estimated-by United Sections in Gifu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 36
Not provided
1) Inflammatory, bilateral or mucinous breast cancer 2) Synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval 3) Severe complication(s), e.g., congestive cardiac failure, coronary failure, cardiac infarction, angina pectoris, arrhythmia, cerebrovascular disease, active gastrointestinal tract ulcer, diabetes, renal failure, hepatic failure, active hepatitis or hepatic cirrhosis. 4) Active infection 5) Interstitial pneumonitis or pulmonary fibrosis identified by chest radiography or chest CT 6) Positive for HBs antigen or HCV antibody 7) Uncontrollable peripheral neuropathy 8) History of drug allergy 9) Pregnant / nursing 10) Severe mental disorders 11) Disqualified by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response rate pCR rate
- Secondary Outcome Measures
Name Time Method Response rate Histological therapeutic effect Safety Breast conserving rate QO