FT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study.
Phase 2
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000003835
- Lead Sponsor
- Osaka Medical College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1. Necessary for adjuvant chemotherapies other than UFT. 2. Treated with oral 5-FU agents previously. 3. Pregnant or breastfeeding. 4. Willing for or possibilities of pregnancy. 5. Recieved the organ transplantation previously. 6. Hypersensitive or underwent severe adverse reactions to fluoropyrimidine. 7. Suffered from serious complications. 8. Having fever or possibility of the infection. 9. Metastatic breast cancer. 10. Having past history or treatment of epilepsy, central nurve system disorder, or psychiatric disease. 11. Difficulty with taking oral drugs or upper gastrointestinal function, or malabsorption syndrome. 12. Judged to be ineligible by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method feasibility
- Secondary Outcome Measures
Name Time Method Safety, disease free survival, overall survival