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Nipple duct lavage (NDL) may be useful for breast cancer risk stratification. Published guidelines recommend that women with a 5‐year Gail risk ≥1.7% should consider undergoing lavage for any fluid‐yielding ducts, but it is not known whether increased breast cancer risk or nipple fluid production predict lavage atypia.One hundred fifty women unselected for breast cancer risk underwent NDL with cannulation of all nipple aspirate fluid (NAF)‐producing ducts and at least 1 dry duct. This resulted in 516 lavage samples. The rate of cytologic atypia was compared for NAF‐positive ducts and NAF‐negative ducts and for women with 5‐year Gail risks ≥1.7% and <1.7%. Ducts from breasts with cancer (N = 113) were excluded from the analysis.The cytologic atypia rate was similar for the 240 NAF‐producing ducts (19%) and the 163 dry ducts (15%; P = .36). No significant differences were observed when atypia was categorized as mild (13% vs 10%; P = .63) or marked (6% vs 4%; P = .53). Among the 83 patients who were unaffected by breast cancer, atypia was diagnosed in 15 of 44 patients (34%) with a 5‐year Gail risk <1.7% and in 11 of 39 patients (28%) with a 5‐year Gail risk ≥1.7% (P = .74).Neither NAF production nor 5‐year Gail risk predicted lavage atypia. Limiting NDL to fluid‐producing ducts in women with a 5‐year Gail risk ≥1.7% significantly reduced the sensitivity of the test for population screening. Cancer 2007. © 2007 American Cancer Society. [ABSTRACT FROM AUTHOR]