Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (OOTR N003)
Phase 2
- Conditions
- Operable breast cancer
- Registration Number
- JPRN-C000000322
- Lead Sponsor
- Organization for Oncology and Translational Research (OOTR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
Male History of drug hypersensitivity Uncontrolled medical condition Significant interstitial pneumonia or pulmonary fibrosis by CT scan or x-ray Suspected of infection with fever Symptomatic Varicella Requiring treatment of pleural or pericardial effusions Severe edema Severe peripheral neuropathy Requiring treatment with the steroid is a necessity beforehand Severe psychiatric disorders Inflammatory breast cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method