Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
- Conditions
- Breast cancer
- Registration Number
- JPRN-C000000397
- Lead Sponsor
- Kyushu Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 150
Not provided
1) Bilateral breast cancer 2)A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 3)Inflammatory breast cancer 4)Male 5)A history of hypersensitivity reaction to any drugs. 6)Uncontrolled medical conditions. 7)Suspected of infection with fever 8)Severe peripheral neuropathy (>Grade 1). 9)Symptomatic varicella. 10)Treatment required pleural or pericardial effusions 11)Severe peripheral edema. 12)Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 13)Patients who are required concurrent treatment by corticosteroids. 14)Severe psychiatric disorders 15)Pregnant or lactation women, or women with suspected pregnancy 16)Patients judged by the investigator to be unfit to be enrolled into the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method Safety, feasibility