breast cancer
Conditions
Interventions
4 cycles of weekly nab-paclitaxel followed by 4 cycles of FEC [weekly nab-paclitaxel] nab-paclitaxel 150 mg/m2 administered weekly on days 1, 8, and, 15 of each 4-week cycle [FEC] 5-FU 500 mg
Sponsors
St. Marianna University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed primary breast cancer 2) Clinical stage T1c-3 N0/M0 or T1-3 N1/M0 3) At least one measurable lesion 4) Age >= 20 years 5) No prior surgery, radiation, chemotherapy and endocrine therapy 6) Required baseline laboratory parameters (within 14 days before registration) Hb: >= 8.0 g/dL WBC: >= 3000 /mm3 and <= 12,000 /mm3 Neu: >= 2,000 / mm3 Plt: >= 75,000 / mm3 T-Bil: <= 2 times ULM AST: <= 2 times ULN ALT: <= 2 times ULN Cre: <= ULN 7) ECOG performance status of 0 &#8211; 2 8) written informed consent
Exclusion criteria
Exclusion criteria: 1) allergy of the medication 2) IHC 3+, IHC 2+ and FISH + 3) Active double cancer 4) Severe complications 5) Symptomatic brain metastasis 6) Severe mental disorder 7) receive blood transfusions within 2 weeks 8) Sever bone marrow suppression, renal dysfunction, liver dysfunction 9) Sever body cavity fluid 10) Patients with diarrhea 11) Active infection or potentiality infection 12) allergy of the nab-paclitaxel, paclitaxel or albumin 13) During pregnancy or lactation 14) Judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| adverse event pathological complete response rate clinical response rate pathological response rate rate of breast-conserving surgery | — |
Primary
| Measure | Time frame |
|---|---|
| Feasibility | — |
Countries
Japan
Contacts
Public ContactKoichiro Tsugawa, M.D.
St. Marianna University School of Medicine Division of Breast and Endocrine Surgery
Outcome results
None listed