Breast Cancer
Conditions
Interventions
EC(Epi-ADM 90mg/m2 and Cyclophosphamide 600mg/m2) is administered. One course is consisted by 3 weeks and repeated to 4 courses. After administrated 4 courses of EC, ABI 260mg/m2 is administered. One
Sponsors
Dokkyo Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically breast cancer confirmed by needle biopsy. 2) Clinical stage T1-3, >=N1, M0 3) expected to radical cure by operation and neoadjuvant chemotherapy 4) has measurable region 5) Age 20 to 70 6) No prior surgery, radiation, chemotherapy and endcrinethrapy 7) Required baseline laboratory parameters (within 2 weeks before registration): Hb more than 9.0g/dl WBC more than 4000 /mm3 Neu more than 2000 / mm3 Plt more than 100,000/mm3 T-Bil less than 1.5 mg/dL AST(GOT) less than 2.5-times the upper limit of normal ALT(GPT) less than 2.5-times the upper limit of normal Cre less than 1.5 mg/dL cardiac electrogram : No clinically important abnormal finding 8)ECOG performance status is 0 to 1 9)Signed informed consent of the patient for the registration by their own volition.
Exclusion criteria
Exclusion criteria: 1) History of sever hypersensitivity 2) Active other malignancies 3) Severe complications (infection, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction within 6 months, heart failure etc.) 4) has psychological illness which became a problem in practice 5) sever bone suppression, renal dysfunction, and liver dysfunction 6) sever pleural effusion or ascites fluid 7) has infection or fever which suspected of infection 8) pregnant or possibility of pregnant 9) Patients judged inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is to evaluate the pathological CR rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is to evaluate the Clinical response rate, pathological response rate, | — |
Countries
Japan
Contacts
Public ContactJun Ito
Dokkyo Medical University Surgery 1
Outcome results
None listed