Breast Cancer
Conditions
Interventions
FEC100 (500/100/500 mg/m2) every 21 days for 4 cycles followed by weekly Paclitaxel 80 for 12 cycles (or weekly Paclitaxel 80 followed by FEC100).
Patients receive zoledronic acid 4mg or an adjusted d
Sponsors
JONIE Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Histologicaly confirmed invasive breast cancer by biopsy. 2.Clinical stage 2A-3B defined as: 1) Tumor diamiter more than 3cm 2)Tumor diamiter more than 2cm and Node positive 3. HER2 negative (less 1 by HercepTest, if 2+ by HercepTest, negative by FISH) 4. Age more than 20 to less than 70 years 5. ECOG PS 0-1 6. Adequate main organ functions 1) WBC more than 3000/mm3 and Neutrophil more than 1500/mm3 2)Hemoglobin more than 9.0g/dl 3)Platelet more than 100,000/mm3 4) AST and ALT more less 2.5x upper limit of normal 5)Serum creatinine less than 1.5x upper limit of normal 6)Normal cardiac function 7)left ventricular ejection fraction more than 50 % 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1.Non-invasive breast cancer and Invasive micropapillary carcinoma 2. Inflammatory breast caner 3. Bilateral breast cancer(synchronous or asynchrous) 4. No prior chemotherapy, endocrine therapy and radiotherapy for breast cancer 5. Active double cancer 6. Patients with myocardial infarction or congestive heart failure at the past history, or patients who need treatment of ischemic hear disease, arryhythmia or valvular disorder. 7. Severe complication(infectious diseases, interstitial pneumonia peripheral neuropathy, uncontrolled diabetes, bleeding tendency) 8. Those who are pregnant, potentially pregnant or breast-feeding 9. Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants) 10.Those known to have active Hepatitis B or C Viral Infection ( HBs(+) or HCV(+) ) 11. Patients have received prior intravenous bisphosphonate within 12 monthes 12. Patient judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate:pCR | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate Breast conserving rate Disease free survival Adverse events | — |
Countries
Japan
Contacts
Public ContactHiroshi Kaise
Tokyo Medical University Hospital Breast oncology
Outcome results
None listed