Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer
Inclusion Criteria:
- Locally advanced breast cancer diagnosed by guided core biopsy
- T > 2 cm (any N), or any T and node positive (needle biopsy is required)
- Non-metastatic disease assessed by computed tomography and bone scintigraphy
- Histological grade 2 and Ki67 > 15% or
- Histological grade 3 or
- Any triple negative (TN) or
- Inflammatory breast cancer (IBC)
- Normal left ventricular ejection fraction (LVEF)
- HER2-negative disease
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 as cardiovascular diseases, chronic obstructive
pulmonary disease (COPD), renal or liver failure, psychiatric disorders
- LVEF value below institutional limits of normal
- Predominant lobular carcinoma histology
- Grade 1 tumors
- Detected or suspicious distant metastasis
- Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than
10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than
ULN, alkaline phosphatase more than 1.5x ULN
- Male sex
- HER2-positive breast cancer