breast cancer
Conditions
Interventions
4 cycles of EC followed by 4 cycles of tri-weekly Nab-paclitaxel [EC] epirubicin 90 mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of each 3-week cycle [Nab-paclitaxel] Nab-paclitax
Sponsors
Saitama Medical Center,Saitama Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed primary breast cancer 2)Clinical stage T1-3,>=N1,M0 3)Expected to radical cure by operation and neoadjuvant chemotherapy 4)At least one measurable lesion 5)Age >=20 and <= 70 6)No prior surgery, radiation, chemotherapy and endocrine therapy 7)adequate function of important organs (within 14 days before registaration) 1. Hemoglobin: >=9.0g/dL 2. WBC: >=4,000/mm3 or Neutrophil: >=2,000/mm3 3. Platelet: >=100,000/mm3 4. T-Bil <= 1.5mg/dL 5. AST <= ULN x 2.5 6. ALT <= ULN x 2.5 7. Creatinin <= 1.5mg/dL 8. Adequate baseline cardiac function on Electrocardiography 8)ECOG performance status 0-1 9)written informed consent 10)Judged eligible based on physicians' decision
Exclusion criteria
Exclusion criteria: 1)History of hypersensitivity reaction 2)Active another cancer 3)Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure. 4)Severe mental disorder 5)Sever bone marrow suppression, renal dysfunction, liver dysfunction 6)Body cavity fluid 7)Active infection or potentiality infection 8)Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 9)Judged ineligible based on physicians' decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical response rate, pathological response rate, rete of breast conserving surgery, adverse event | — |
Countries
Japan
Outcome results
None listed