Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer
Inclusion Criteria:
- Diagnosis of locally advanced breast cancer
- T > 2 cm (any N), or any T and positive node(needle biopsy is required if tumor size
is less than 2cm)
- Non-metastatic disease confirmed by computerized tomography and bone scan
- HER2 positive by IHC (+++) and/or Fish (+) according to international definitions
(ASCO 2007)
- Normal left ventricular ejection fraction (LVEF)
- Indication of preoperative chemotherapy
- multifocal tumors acceptable provided that the largest tumor is Her2-positive
- ECOG 0-1
Exclusion Criteria:
- Another malignancy within the last 5 years (except curatively treated skin carcinoma,
in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular
carcinoma of the breast)
- Clinically significant comorbidities such as cardiovascular diseases, COPD, renal or
liver impairment, psychiatric disorders
- LVEF value below institutional limits of normal range
- Detected or suspected distant metastasis
- Neutrophils lower than 1,500/µL, platelets lower than 100,000/µL, hemoglobin lower
than 10 g/dL, AST higher than 2.5x upper limit of normal (ULN), total bilirubin
higher than ULN, alkaline phosphatase more than 1.5x ULN