Primary breast cancer
Conditions
Interventions
12 cycles of wPTX followed by 4 cycles of ADM+PTX (AP) PTX 80mg/m2 12 cycles 1) day1
PTX 80mg/m2 after completion wPTX, day22 would be day1 and followed by AP 4 cycles (q3weeks) 1) day1
ADM 50mg/m2 2) day1
PTX 150mg/m2
Sponsors
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed primary breast cancer 2)Tumor diamiter >2cm or Node positive 3) No prior chemotherapy for breast cancer 4) Age >20 y 5)ECOG PS 0-1 6)Hormone receptor negative; ER(-) and PgR(-), less than 10% by immunohistochemistry 7)HER2 negative (<1 by HercepTest, if 2+ by HercepTest, Signal ratio <2.0 by FISH) 8) Written informed consent 9) No operation for breast cancer 10) Adequate main organ functions
Exclusion criteria
Exclusion criteria: 1)Severe complication 2)Inflammatory breast caner and male breast cancer 3)Ischemic heart disease or arrhythmia which needs medical treatment (history of myocardial infarction occured within 6 months) 4)Uncontrolled diabetes 5)Suspicious of infection 6)History of serious hypersensitivity or history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate 7)During pregnancy or lactation 8)Patient judged inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response; pCR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate Disease free survival Overall survival Breast conserving rate Treatment compliance Biomarkers | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group (SBCCSG) Secretariat Division (Shintoshin Ladies' MammoClinic)
Outcome results
None listed