Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000004340
- Lead Sponsor
- Kitasato University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 30
Not provided
1)patients receiving oral 5-FU based chemotherapy 2)with active double cancer 3)with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis) 4) pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 5)with history of mental disorder or treating it at the moment 6)with history of severe allergy 7)with severe allergy to 5-FU based drug 8)patients receiving 5-FU based chemotherapy 9)patients receiving Flucytosine 10)Bilateral breast cancer, either simultaneous or metachronal 11)inflammatory breast cancer 12)Impossible to take oral drugs 13)doctor's decision not to be registered to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method feasibility, safety
- Secondary Outcome Measures
Name Time Method disease free survival, overall survival, drug compliance