EFFECT OF TAMOXIFEN ON PROLIFERATIVE BREAST DISEASE

他莫昔芬对增殖性乳腺疾病的影响

• 批准号: 3549729
• 负责人: JOHN R WARD
• 金额: $ 21.49万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-02-22 至 1996-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3549729
• 关键词: biomarker; breast neoplasm /cancer diagnosis; breast neoplasms; cancer risk; cellular oncology; chemoprevention; clinical trials; cooperative study; female; fine needle aspiration; human subject; human therapy evaluation; mammary disorder; neoplasm /cancer chemotherapy; preneoplastic state; tamoxifen

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.

拟议研究的主要目的是：2）确定一组 通过检测一种中间标记物， 增生性乳腺疾病，在一个先前患有轻微癌症的女性中， 乳房 2)进行短期安慰剂对照随机 他莫昔芬的化学预防试验，以评估其改变 乳腺增生性疾病。 接受初次手术/放射治疗的女性， 最小程度的单侧浸润性癌（局部疾病伴肿瘤 直径为2 cm或更小）或原位癌，将使用 系统的四象限细针穿刺细胞学取样， 对侧乳房。 120名患有中度至重度或非典型导管炎的女性 增生将被随机分配接受他莫昔芬或 安慰剂，然后用系列细针抽吸，以确定 影响这个中间终点。 这场审判意味着 抗雌激素在化学预防中的作用机制，以及 成功将支持抗雌激素的化学预防试验， 乳腺癌作为终点。