Breast cancer
Conditions
Interventions
Nab-paclitaxel followed by FEC Nab-paclitaxel 100 mg/m2 i.v. weekly for 12 weeks followed by FEC (5-FU 500mg/m2 i.v.
Epirubicin 100 mg/m2 i.v. [or if given with Trastuzumab 75 mg/m2 i.v.]
Cyclophosphamide 500 mg/m2 i.v.) on Day 1 every 21 days for 4 cycles
Sponsors
Wakayama Medical University
Minami Wakayama Medical Center Hashimoto Municipal Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed primary breast cancer 2) Clinical stage I-IIIB 3) Patients who scheduled for surgery after neoadjuvant chemotherapy 4) With estimative lesion 5) Age >= 20 years 6) No prior surgery, radiation, chemotherapy and endocrine therapy 7) ECOG performance status of 0 or 1 8) Required baseline laboratory parameters (within 14 days before registration) WBC >= 4,000/mm3 Neu >= 2,000/mm3 Plt >= 10.0x104/mm3 Hb >= 9.0g/dL AST <= 100 IU/L ALT <= 100 IU/L T-Bil <= 1.5mg/dL Cre <= 1.5mg/dL 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Allergy of the medication 2) Synchronous or metachronous (within 5 years) double cancers 3) Serious complication 4) Contraindication to the study drugs 5) Peripheral neuropathy 6) Pregnancy, breast feeding or wish of future bearing 7) Patients considered inappropriate by the study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Breast conserving rate Adverse event Rate of patients with residual peripheral neuropathy | — |
Countries
Japan
Outcome results
None listed