Breast Cancer
Conditions
Interventions
Neo-adjyuvant chemotherapy as 12 weeks of nab Paclitaxel followed by 4 cycles of FEC weekly nab-paclitaxel:nab-paclitaxel 100 mg/m2 administered weekly on days 1, 8, and, 15 of 4-week cycle, Trastuz
Sponsors
University of Tsukuba
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed primary breast cancer 2.Clinical stage T1N1M0 or T2-3N0-2M0 3.No prior surgery, radiation, chemotherapy and endocrine therapy 4.At least one measurable lesion 5.ECOG performance status 0-2 6.Adequate baseline organ function 7.Adequate cardiac function 8.written informed consent
Exclusion criteria
Exclusion criteria: 1.Severe complications 2.past medical history of severe drug allergy 3.allergic reaction of the nab-paclitaxel, paclitaxel or albumin 4.active double cancer 5.inflammatory breast cancer 6.during pregnancy or breast feeding 7.severe peripheral neuropathy 8.interstitial pneumonaitis 9.serious body cavity fluid 10.HBsAf+ or HCVAb+ 11.Judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical response rate rate of breast-conserving surgery adverse event feasibility | — |
Countries
Japan
Contacts
Public ContactHiroko Bando
University of Tsukuba Breast and Endocrine Surgery
Outcome results
None listed