Breast Cancer
Conditions
Interventions
CPA/EPI/5-FU(500/100/500)/q3wks x 4 followed by paclitaxel(80)/qwk x 12/Trastuzumab/q3wks x 4
CPA/EPI/5-FU(500/100/500) x 4 followed by docetaxel (75)/q3wks x 4/Trastuzumab/q3wks x 4
Sponsors
Office for cordination of Herceptin trial
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed invasive, but non- inflammatory carcinoma of the breast confirmed by core-needle biopsy 2. Clinical stage II to IIIA and satisfy criteria as below Tumor size: Less than 2cm and axillary node positive diagnosed by ultrasound or Tumor size: More than 2cm diagnosed by ultrasound 3. In multifocal tumor on the ipsilateral breast, at least one tumor satisfies criteria 2. 4. Case with simultaneous cancer on the both breasts, or metachronous breast cancer, is excluded 5. Overexpression of HER2 by IHC 3+ or FISH + 6. Hormone-sensitivity of primary tumor is no object 7. PS (ECOG) 0-2 8. Adequate organ function as below [Bone marrow] White blood cell count >= 3,000/uL, or granulocyte count >= 1,500/uL Platelet count >= 100,000/uL [Liver function] AST and ALT <= 60IU/L Total Bilirubin <= 1.5mg/dL [Renal function] Serum creatinine <= 1.5mg/dL [Cadiac function] (1) ECG normal or minor abnormality with no-need of treatment (2) No history of ischemic cardiac disease, or cardiomyopathy (3) Ejection fraction more than 60% by ultrasound 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant and nursing 2. Concomitant infectious disease 3. History of hypersensitivity to Cremophor EL(polyoxethylated castor oil) or polysorbate 4. Interstitual pneumonia or lung fibrosis 5. Hepatitis Virus B antigen positive 6. Diabetes Mellitus with uncontrolled status or insulin-therapy 7. Difficulty to participate because of mental disorder 8. Simultaneous double-cancer (exclude carcinoma in situ)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological CR (pCR) rate Definition: no evidence of residual cancer in axillary lymph node and no evidence of residual invasive cancer in breast | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival Adverse Events in neoadjuvant therapy PK study of Neoadjuvant Trastuzumab (10 patients of each arm) To evaluate predictive factors of pCR by cDNA array | — |
Countries
Japan
Contacts
Public ContactMasashi Ando, MD
National Cancer Center Hospital Department of breast, first outpatient division
Outcome results
None listed