Luminal B-like (HER2-negative) or triple-negative operable breast cancer
Conditions
Interventions
Four cycles of nab-paclitaxel 260 mg/m2 every 3 weeks followed by 4 cycles of FEC (5-FU 500 mg/m2, Epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) every 3 weeks
Sponsors
Kyushu Breast Cancer Study Group (KBC-SG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed breast cancer 2) Clinical T1-3, N0-2, M0 and operable breast cancer after neoadjuvant chemotherapy 3) Luminal B-like(HER2-negative) or Triple-negative breast cancer 4) 20 years old and more than 20 years old, and less than 70 years old 5) mesurable disease (RECIST ver 1.1) 6) No any previous treatment for breast cancer 7) Performance status 0-1 8) keeping majour organ function with all condition below within 2 weeks before enrollment WBC, > 4000/mm3 and < 12,000 Neutropil, > 2000/mm3 platelets, > 100,000/mm3 Hb 10.0 g/dl ALT and AST, within 2x UNL T-bil, < 1.5 mg/dl Cr, < 1.5 mg/dl ECG, within normal limit (no severe arrythmia) UCG and MUGA scan, LVEF < 55% 9) indication for neoajuvant chemotherapy 10) Submission of needle biopsy sample before treatment and surgical specimen after neoajuvant chemotherapy and written informed consent
Exclusion criteria
Exclusion criteria: 1) clinically important cardiac disorder and past history of this 2) Severe medical disorders (uncontrolled DM, hypertension, renal failure, liver failure, clinically significant infection and mental disorders) 3) pregnant and nursing female 4) active double cancer 5) lung fibrosis and intestinal pneumonisa 6) allergy reaction for drugs is using in this study 7) Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate based on subtype | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast conserving rates, response rates, safety, disease-free survival, overall survival, response rates of nab-paclitaxel,safety of nab-paclitaxel and identification of predictive factors for neoadjuvant chemotherapy and prognostic factors for patients after neoajuvant chemotherapy | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Clinical Hematology Oncology Treatment Study Group Kyushu Breast Cancer Study Group
Outcome results
None listed