TAMOXIFEN EFFECT ON PROLIFERATIVE BREAST DISEASE

拟议研究的主要目的是：2)确定一组 通过检测中间标志物来检测乳腺癌高危女性， 增殖性乳腺疾病，在既往微小癌症患者中为1例 胸部。2)进行短期安慰剂对照的随机试验 用他莫昔芬进行化学预防试验以评估其修饰能力 这些妇女中的增生性乳房疾病。 曾接受过初级外科/放射治疗的妇女 单侧微小浸润性癌(局部病变伴肿瘤 直径小于或等于2厘米)或原位癌将使用 系统性四象限细针抽吸细胞学检查 相反的乳房。120例中重度或不典型导管 增生症患者将随机分配接受他莫昔芬或 安慰剂，然后进行连续细针抽吸，以确定 对此中间终结点的影响。这项试验具有以下影响 抗雌激素在化学预防中的作用机制，如果 成功将支持抗雌激素的化学预防试验 以乳腺癌为终点。

The primary aims of the proposed study are to: 2) Identify a group of women at high risk for breast cancer by detecting an intermediate marker, proliferative breast disease, in women with prior minimal cancer in one breast. 2) Perform a short-term placebo-controlled randomized chemoprevention trial with tamoxifen to evaluate its ability to modify proliferative breast disease in these women. Women who have undergone primary surgical/radiation therapy for unilateral invasive cancer of minimal extent (local disease with tumor diameter of 2 cm or less) or carcinoma in situ will be evaluated using systematic four-quadrant fine-needle aspiration cytologic sampling of the opposite breast. 120 women with moderate to severe or atypical ductal hyperplasia will be randomly assigned to receive either tamoxifen or placebo and followed with serial fine-needle aspirates to determine the effect on this intermediate endpoint. This trial has implications for the mechanism of action of anti-estrogens in chemoprevention, and if successful will support chemoprevention trials of anti-estrogens with breast cancer as an endpoint.