| Exclusion Criteria: | 1) Patients with a history of DCIS or synchronous DCIS of the contralateral breast regardless of therapy are eligible. Those with synchronous invasive breast cancer are NOT eligible.
2) Patients with a history of ipsilateral DCIS treated by local excision with or without hormonal therapy are eligible. Those treated with radiation therapy are NOT eligible.
3) Patients with a history of non-breast malignancies are eligible if they have remained disease-free for 5 years since completing their initial treatment regimen and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ and basal cell and squamous cell carcinoma of the skin.
4) Patients must NOT have had any surgical axillary staging procedure prior to study entry. However, patients who have had FNA of an axillary node are eligible.
5) Patients must NOT have definitive clinical or radiologic evidence of metastatic disease.
6) Patients must NOT have a prior history of invasive breast cancer
7) Patients must NOT have had treatment given for this breast cancer prior to study entry. (The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery.
8) Patients must NOT be taking any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (Patients are eligible if this therapy is discontinued prior to study entry.) Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
9) Patients must NOT be receiving therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to study entry.)
10) Patients must NOT have had prior therapy with anthracyclines or taxanes for any malignancy.
11) Patients must NOT have non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude treatment with either of the treatment regimens.
12) Patients must NOT have cardiac disease that would preclude the use of epirubicin or trastuzumab. This includes active cardiac disease a) angina pectoris that requires the use of antianginal medication; cardiac arrythmia requiring medication; b) severe conduction abnormality; c) clinically significant valvular disease; d) cardiomegaly on chest x-ray; e) ventricular hypertrophy on EKG; or f) patients with poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension that is well controlled on medication are eligible).
13) CONTINUED FROM EXCLUSION 14 - History of cardiac disease g) myocardial infarction documented as a clinical diagnosis or by EKG or any other tests h) documented congestive heart failure; i) documented cardiomyopathy.
14) Patients must NOT have sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0.
15) Patients must NOT have had administration of any investigational agents within 30 days before study entry.
16) Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration. Women who are breast feeding are NOT eligible.
17) Patients must NOT have psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements. |