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A PHASE III RANDOMIZED STUDY OF EXEMESTANE PLUS PLACEBO VERSUS EXEMESTANE PLU

依西美坦加安慰剂与依西美坦 PLU 的 III 期随机研究

基本信息

批准号：
7952230
负责人：
ROWAN A CHLEBOWSKI
金额：
$ 29.5万
依托单位：
LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-12-01 至 2009-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7952230
关键词：
Adverse effects Age Anti-Inflammatory Agents Aromatase Inhibitors Biopsy Blood Clot Blood Tests Blood coagulation Bone Density Breast Clinical Research Computer Retrieval of Information on Scientific Projects Database DEXA Endometrial Carcinoma Estrogens Exemestane Family Funding Grant Institution Leg Life Lung Malignant Neoplasms Mammography Menopause Non-Steroidal Anti-Inflammatory Agents Observational Study Participant Pharmaceutical Preparations Phase Placebos Postmenopause Quality of life Questionnaires Randomized Randomized Controlled Clinical Trials Recording of previous events Reproductive History Research Research Personnel Resected Resources Risk Risk Reduction Role Selective Estrogen Receptor Modulators Source Steroids Stroke Tamoxifen Testing Tissues United States National Institutes of Health Woman base breast density cancer chemoprevention cancer risk celecoxib inflammatory pain interest malignant breast neoplasm pre-clinical

项目摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Breast cancer is the most common malignancy in Western women. Tamoxifen is an agent commonly used to treat breast cancer which blocks some of estogen's actions on the breast and other tissues. In randomized trials, tamoxifen has established "proof of principle" for breast cancer chemoprevention by reducing breast cancer risk in women at increased risk of breast cancer. However, rare but life-threatening side effects of tamoxifen, including endometrial cancer, blood clots in lungs and legs and stroke have severely limited general use of tamoxifen for risk reduction. The class of aromatase inhibitors are used to treat breast cancer in postmenopausal women by reducing estrogen levels and are not associated with increased endometrial cancer, blood clots or strokes. When agents in this class were found to reduce risk of new contralatral breast cancer in postmenopausal women with resected breast cancer, interest in their potential use for breast cancer risk reduction developed. Celecoxib is a non-steroid anti-inflammatory agent (NSAID) prescription agent used to treat pain and inflammatory condition. Preclinical and observational studies now suggest a potential role for breast cancer risk reduction of these agents as well. The current study will evaluate whether exemestane either alone or together with celecoxib can reduce the risk of breast cancer with a favorable risk to benefit ratio in otherwise healthy postmenopausal women at increased risk for developing breast cancer based on their age or mammogram breast density. For entry, women must be postmenopausal and be at increased breast cancer risk based on a calculated Gail risk score incorporating family and reproductive history, age 60 years or greater, a certain prior benight breast biopsy results. Women with concurrent NSAID use and those with recent menopausal homrone therapy or SERM use are not eligible. Participants will have a history and physical exam at baseline, blood tests and recent prior mammogram and bone density test (DEXA). A quality of life questionnaire and information on other medication will be collected.

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