early breast cancer
Conditions
Interventions
Neoadjuvant chemotherapy: CEF (EpiADR 100mg/m2 D1, CPA 500mg/m2 D1, 5FU 500mg/m2 D1 per 3 weeks) 4 cycles, then weekly paclitaxel 80mg/m2 for 12 weeks. zoledronic acid: 4mg + saline 100ml div for 15
Sponsors
Division of Medical Oncology and Breast Surgery, Cancer Institute Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) ECOG Performance status of 0 to 2 2) diagnosed as breast cancer with biopsy 3) T 3cm or more, or lymph-node positive stage IIA-Stage IIIB, HER2-negative primary breast cancer 4) Adequate organ function such as (1) WBC: 3000 /cmm or more, and WBC< 12, 000 /cmm (2) Hb: 9.0 g/dl or more (3) Platelet : 100000 /cmm or more (4) GOT/GPT: less than 3x upper normal limit (5) T. Bil :1.5 mg/dl or less (6) Cr: 1.5 mg/dl or less (7) no cardiac dysfunction (8) EF: 50% or more 5) A written informed consent is obtained
Exclusion criteria
Exclusion criteria: 1) non-invasive or minimally-invasive breast cancer 2) stage IV or inflammatory breast caner 3) male breast cancer 4) Patients who have treated with endocrine therapy, chemotherapy, or radiation therapy 5) Patients with previous or concomitant active malignancy 6) Patients who have serious complication (infection, cardiac disease, lung fibrosis, interstitial pneumonitis, bleeding tendency, etc.) 7) HB hepatitis 8) Patients who have poor-controlled DM 9) Patients who have hypersensitivity to bisphosphonates 10) Patients who needs invasive dental procedures 11) Patients who is pregnant, lactating or willing to be pregnant 12) Other conditions judged as inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response rate, breast conservation rate, axillar lymph node complete response rate, distant metastasis-free survival, disease-free survival, overall survival, adverse effects, changes of disseminated tumor cells, circulating tumor cells, and circulating endothelial cells | — |
Countries
Japan
Contacts
Public ContactShunji Takahashi
Cancer Institute Hospital Division of Medical Oncology
Outcome results
None listed