A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000005100
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Female
- Target Recruitment
- 40
Not provided
1) Inflammatory breast cancer and bilateral breast cancer 2) Previous (less than 5 years) or current history of malignant neoplasm 3) Known immediate or delayed hypersensitivity reaction or contraindication to drugs chemically related to any of the study treatment 4) Severe complications (uncontrolled diabetes mellitus, heart failure, interstitial pneumonia or pulmonary fibrosis etc.) 5) Sever bone marrow suppression 6) Renal dysfunction (serum Cre is more than ULN), liver dysfunction ( T-Bil or AST/ALT is more than 2.5 times ULN ) 7) During administration of fluoropyrimidines 8) Active infection (more than 38.0C) 9) During administration of flucytosine, phenytoin, warfarin potassium 10) During administration of pentostatin 11) During pregnancy or lactation 12) Patients judged inappropriate by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is to evaluate the pathological CR rate.
- Secondary Outcome Measures
Name Time Method Secondary endpoint is to evaluate the clinical response rate and relapse- free survival and safety.