Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

Inclusion Criteria:

Histologically confirmed invasive carcinoma of the breast
Tumors must be less than or equal to 3cm in greatest dimension
Must have node-negative breast cancer according to teh AJCC 7th edition
ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods
HER-2 positive: IHC 3+ or FISH >2
Bilateral breast cancers that individually meet eligibility criteria are allowed
Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides must be sent to DFCI for testing
Less than or equal to 84 days from mastectomy or from axillary dissection or sentinel node biopsy if the patient's most extensive breast surgery was a breast-sparing procedure
All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
18 years of age or older
ECOG Performance Status of 0 or 1
Adequate bone marrow function, hepatic function, and renal function as outlined in protocol
Left ventricular ejection fraction of greater than or equal to 50%
Willingness to discontinue any hormonal agent prior to registration and while on study
Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study
Patients with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy
Patients undergoing breast conservation therapy must not have any contraindications to radiation therapy

Exclusion Criteria:

Pregnant or nursing women
Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes
History of prior chemotherapy in past 5 years
History of prior trastuzumab therapy
Active, unresolved infection
Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent
Sensitivity to benzyl alcohol
Grade 2 or greater neuropathy per NCI's CTCAv3.0. (Exception: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair).
Active cardiac disease as outlined in protocol.