Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial

Inclusion Criteria

INCLUSION CRITERIA

Women of any age with clinical stage II breast cancer who met the following criteria:

Patients with stage II breast cancer will include primary tumor less than or equal to 5 cm
in size with axillary lymph nodes which are clinically ([N0 or N1] [T1N1, T2N0, T2N1]).

Patients will be staged according to the 1986 AJCC TMM classification.

Patients with bilateral breast cancer will be eligible provided at least one tumor is
invasive and classified as stage I or II, and neither breast is stage III.

Histologic sections of the breast tumor must be classified as an invasive primary breast
neoplasm of epithelial origin.

Patients must be geographically accessible for follow-up and willing to return for the
follow-up at the NCI.

Patients must be mentally competent to understand and give informed consent for the
protocol.

Estrogen receptor (ER) status can include ER positive, negative, or unknown.

Patients with prior cancers may be eligible as long as they have received curative therapy
and have had no evidence of recurrence for greater than or equal to 10 years.

EXCLUSION CRITERIA

Patients will be excluded from this protocol for the following reasons:

Advanced local disease or distant metastases (stage III or IV).

Previous therapy to the breast other than excisional biopsy.

Pregnancy.

Unwillingness to use birth control during chemotherapy.

Chronic disease such as heart, lung, liver, kidney, blood or metabolic disorders which may
render the patient a poor risk for surgery or chemotherapy. Specifically, liver function
- SGOT, SGPT, alkaline phosphatase and total bilirubin should be less than 1.5 x the upper
limits of normal. Renal function - creatinine should be less than 1.7 and/or creatinine
clearance should be greater than 45 ml/min. If there is any history of cardiac disease,
patients must have a normal ejection fraction on MUGA scan and no angina.