A Phase II trial of alternate-day S-1 for anthracyclin?taxane refractory metastatic breast cancer
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000017034
- Lead Sponsor
- Tokyo Women`s Medical UniversityDepartment of Surgery II
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open public recruiting
- Sex
- Female
- Target Recruitment
- 22
?Female unresectable metastatic or recurrence breast cancer.
?Histologically confirmed invasive breast cancer.
?At least one evaluable lesion.
?Evaluated ER and PgR status by IHC.
?Evaluated HER2(-) by IHC/FISH.
?Prior treatment of anthracyclin/taxane.
?20 to 75 years old at diagnosis.
?Adequate major organ function.
?WBC>=3,000/mm3 or Neu>=1,500/mm3
?Plt>=100,000 /mm3
?Hb>=9.0 g/dL
?AST/ALT <=ULN*2.5
?Bil<=ULN*1.5
?Cr<=ULN*1.5
?CCr>=60mL/min
?Performance status(ECOG) 0 or 2
?Non life threatening.
?Written informed consent.
?History of drug-hypersensitivity.
?Evaluated HER2(+) by IHC/FISH.
?Active double cancer.
?Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
?Male patient.
?Infection or suspected infection.
?Abnormal ECG or serious cardiac disorder.
?History of congestive cardiac failure.(NYHA class III/IV)
?Complication needed hospitalization.
?Administration of flucytosine phenytoin or warfarin potassium.
?Mental disease with difficulty of taking part in this study.
?Administration of steroid.
?HBV related marker (+).
?Gastrointestinal bleeding.
?Current pregnancy and lactation, or possibility of pregnancy.
?Ineligible based on decision of an investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method