Inclusion Criteria

Inclusion criteria

- Histologic diagnosis of invasive adenocarcinoma of the breast diagnosed by core,
incisional, or excisional biopsy.

- All of the following staging criteria must be met: Primary tumor must be operable and
staged as cT1-3 by clinical evaluation. Ipsilateral nodes must be cN0-1 by clinical
evaluation. No evidence of metastatic disease (M0).

Exclusion criteria:

- Patients with any history of breast malignancy including DCIS (patients with a
history of Lobular Carcinoma in Situ (LCIS) are eligible).

- Treatment including radiation therapy, chemotherapy, and/or hormonal therapy
administered for the currently diagnosed 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 after diagnosis and before study entry.

- Patients who will be receiving preoperative chemotherapy.

- Bilateral malignancy (including DCIS).

- Other non-breast malignancies unless the patient is considered disease-free for 5
years before study entry and is 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, melanoma in situ,
colon carcinoma in situ, and basal cell and squamous cell carcinoma of the skin.