breast cancer
Conditions
Interventions
4 cycles of EC followed by 4 cycles of weekly nab-paclitaxel EC Epi-ADM 90 mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of each 3-week cycle weekly nab-paclitaxel nab-paclitaxel
Sponsors
Tokai University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Histologically confirmed primary breast cancer Clinical stage T1c-3 N0/M0 or T1-3 N1/M0 At least one measurable lesion over 20 years old No prior surgery, radiation, chemotherapy and endocrine therapy Adequate baseline organ function (within 14 days before registration) Hb--over 8.0 g/dL WBC--over 3000 /mm3 and under 12,000 /mm3 Neu--over 2,000 / mm3 Plt--over 75,000 / mm3 T-Bil--under 3 times ULM AST/ALT--under 3 times ULN Cre--under ULN ECOG performance status--0-2 written informed consent
Exclusion criteria
Exclusion criteria: past medical history of drug allergy HER2 positive breast cancer (IHC 3+, IHC 2+ and FISH +) Active double cancer Severe complications Symptomatic brain metastasis Severe mental disorder History of blood transfusions within 2 weeks Sever bone marrow suppression, renal dysfunction, liver dysfunction Body cavity fluid watery diarrhea on registration Active infection or potentiality infection allergic reaction of the nab-paclitaxel, paclitaxel or albumin During pregnancy or lactation 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 |
|---|---|
| adverse event clinical response rate pathological response rate rate of breast-conserving surgery feasibility overexpression rate of SPARC | — |
Countries
Japan
Contacts
Public ContactYasuhiro Suzuki
Tokai University School of Medicine Division of Breast and Endocrine Surgery, Department of Surgery
Outcome results
None listed