This article reviews recent data that support consensus recommendations for management of patients with axillary node-negative breast cancer. Fewer false-negative results, provision of adequate tissue samples for further diagnostic studies, and other advantages make excisional biopsy the preferred diagnostic approach for most clinicians. For most women with node-negative breast cancer, breast conservation surgery combined with radiation therapy provides survival equivalent to total mastectomy and axillary dissection, along with superior cosmetic results. Adjuvant systemic therapy with either cytotoxic drugs or hormonal agents can significantly reduce the risks of recurrence and death in women whose primary lesions indicate a substantial risk for these events. Data from six randomized clinical trials show that adjuvant therapy with intravenous methotrexate and fluorouracil (with or without oral or intravenous cyclophosphamide) reduces the rate of relapse after surgery for node-negative breast cancer. Adjuvant therapy with tamoxifen (20 mg/d for at least 2 years) reduces tumor recurrence by 25% to 33% and improves survival by 16% in women with node-negative, estrogen receptor-positive breast cancer. Prognostic indicators with demonstrated utility in determining a women's risk of recurrence after surgery for breast cancer include tumor size and histologic subtype, nuclear grade, and estrogen receptor status (with progesterone receptor status, when available). A number of issues in need of additional clinical investigation (to establish optimal therapy and evaluate new prognostic marker) are discussed.