Randomized phase II study with six cycles of Docetaxel/cyclophosphamide (TC) and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC100) followed by docetaxel for treating hormone receptor-negative breast cancers
Phase 2
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000002215
- Lead Sponsor
- Yokohama City University medical center Breast and thyroid surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1)A history of hypersensitivity reaction to any drugs. 2)seriously compromised 3)Suspected of infection with fever 4)peripheral neuropathy 5)Treatment required pleural or pericardial effusions 6)complication of the active other malignancies 7)Inflammatory breast cancer 8)Male 9)Pregnant or lactation women, or women with suspected pregnancy 10)edema 11)Symptomatic varicella 12) Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 13) Patients who are required concurrent treatment by corticosteroids except for premedication 14)psychological disorders 15) 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 histological effect
- Secondary Outcome Measures
Name Time Method Safety Breast conservation rate Recurrence-free survival Overall survival