Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed invasive primary breast cancer

  • Clinical (radiologic) stage II or III disease
  • No T4d disease
  • No inflammatory breast cancer

• ErbB2-negative disease OR patient cannot receive trastuzumab treatment

  • ErbB2-positive disease defined as either immunohistochemistry 3+, or FISH- or CISH-positive; immunohistochemistry 2+ is to be determined according to FISH or CISH results

PATIENT CHARACTERISTICS:

• Mobile
• ECOG performance status 0-1
• Normal cardiac function (LVEF > 50%)
• Hemoglobin ≥ 10.0 g/dL
• Absolute neutrophil count ≥ 1,500/μL
• Platelet count ≥ 10 x 10^4/μL
• Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
• Total bilirubin ≤ 1.5 times ULN
• AST/ALT ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to swallow tablet whole with water
• No prior motor or sensory neurotoxicity CTCAE ≥ grade 2
• No other serious disease or medical condition

• No uncontrolled or serious cardiovascular disease, including any of the following:

  • Myocardial infarction within the past 6 months
  • New York Heart Association class III or IV heart failure
  • Uncontrolled angina pectoris
  • Clinically significant pericardial disease
  • Cardiac amyloidosis
• No history of symptomatic or therapy-requiring cardiac arrhythmia CTCAE grade 3 (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation)
• No asymptomatic sustained ventricular tachycardia
• History of atrial fibrillation or cardiac arrhythmia controlled by medication allowed
• No uncontrolled infection, unstable peptic ulcer, uncontrolled diabetes, or any other contraindication to corticosteroid administration
• No history of infection or any other serious medical event which may cause any functional injury in the affected patient and consequently, interfere with continuing the study treatment
• No history of hypersensitivity to taxanes, fluorouracil, or S-1
• No significant gastrointestinal malfunction that will affect S-1 absorption
• No history of other cancer within the past 5 years except properly treated carcinoma in situ of the uterine cervix or basal cell or squamous cell carcinoma of the skin
• No severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
• No psychological, social, family, or geographical condition, or difficult circumstance that would preclude follow-up or compliance with the protocol

PRIOR CONCURRENT THERAPY:

• No prior systemic treatment for this cancer (e.g., radiotherapy, chemotherapy, hormone therapy, or biological therapy)
• No prior preoperative topical treatments (e.g., incomplete surgery or radiotherapy) for this cancer

• No concurrent drug(s) that may potentially cause changes in the pharmacological activity of S-1 formulation, including any of the following:

  • Allopurinol
  • Phenytoin