metastatic breast cancer
Conditions
Interventions
1) Paclitaxel 80mg/m2 (day 1,8 q3W) 2) Capecitabine 1650mg/m2 (day 1-14 followed by a week rest q3W)
Sponsors
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed breast carcinoma. 2. clinically distant metastasis 3. previous teatment is nothing or only 1st line chemotherapy. (but the case, after taxane is prescribed in adjuvant or neo ajuvant 6months or more has elapsed, is the register possible not in addition to 1 regimen) 4. Age>=20 5. PS(ECOG) 0-1 6. Written informed consent 7. expected survival time: more than 6 months 8. Adequate organ function
Exclusion criteria
Exclusion criteria: 1. severe complication 2. The brain metastasis which possesses condition 3. Past history of allergic reaction 4. Past history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate 5. which has the use history of taxane or 5' DFUR or capecitabine (but the case, after taxane is prescribed in adjuvant or neo ajuvant 6months or more has elapsed, is the register possible not in addition to 1 regimen). 6. Peripheral neuropathy >= grade 2 in prior chemotherapy 7. Pregnant or lactating women 8. Doctor's decision for exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event overall survival (OS) Time To Progression (TTF) Response rate, PFS and OS for breast cancer with ER/PgR/HER2 negative | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group (SBCCSG) Executive office
Outcome results
None listed