Statement: Patients with HER2 positive tumors are excluded from the primary trial, but may be included in the secondary trial.
Primary_evidence: Inclusion Criteria:   Female patient  18 years of age   Histologically proven stage II or III adenocarcinoma of the breast   Must be candidate for neoadjuvant treatment (Tumor size  2 cm, T2, T3, T4 and/or clinical N1 or N2).   HER-2/neu 1+ or 2+ by immunohistochemistry   Must have operable tumor.   Performance status of 2 or better per SWOG criteria   LVEF  55% by echocardiogram performed within 4 weeks prior to treatment initiation   If patient of childbearing potential, pregnancy test is negative   Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.   Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 9 g/dL   Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min   Adequate hepatic function: transaminases < 2.5 x upper limit of normal and total bilirubin < 1.5 mg/dL   Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.   Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration. EXCLUSION CRITERIA:   Patient with metastatic breast cancer.   Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry   Women with HER 2 FISH amplified tumors (FISH ratio >2.2)   Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded.   Locally advanced, inoperable tumors will be excluded.   The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.   History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias   Ejection fraction < 55%   Pregnancy or lactation   Patients with inadequate laboratory values (as defined above) are excluded from study.   Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.   Patients with active infection are excluded from study.   Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).   Patients with emotional limitations are excluded from study.
Secondary_evidence: Inclusion Criteria:   At least 18 years of age   Willing and able to provide informed consent   Reporting daily hot flashes   Able to read, write, and speak English   Postmenopausal to limit sample variability (> 12 months amenorrhea)   Greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.   These criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. Menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users. Exclusion Criteria:   Exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances.