Luteal Adjuvant Oophorectomy in Vietnamese Breast Cancer

黄体辅助卵巢切除术治疗越南乳腺癌

基本信息

批准号：
7354774
负责人：
Richard Reed Love
金额：
$ 53.31万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-05-01 至 2009-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7354774
关键词：
Adjuvant Adjuvant Therapy Age Attention Authorization documentation Axillary lymph node group Bilateral oophorectomy Biological Assay Blood Blood specimen Breast Characteristics Chinese People Cities Clinical Trials Clinical Trials Data Monitoring Committees Conduct Clinical Trials Corpus Luteum Cyst Cost Effectiveness Analysis Data Disclosure Disease Disease-Free Survival Ensure Epithelium Estradiol Estrogens Face Filipino Frequencies General Hospitals Goals Hormonal Hormone Receptor Hormones Hospitals Human Resources Institution Instruction Last Name Length Life Love Luteal Phase Luteinizing Hormone Mastectomy Menstrual cycle Modified radical mastectomy Morbidity - disease rate Names National Cancer Institute Numbers Operative Surgical Procedures Ovariectomy Ovary Participant Pathologic Pathology Patients Phase Philippines Positive Lymph Node Premenopause Principal Investigator Probability Progesterone Progesterone Receptor Status Protocols documentation Publishing Randomized Randomized Clinical Trials Randomized Controlled Trials Recording of previous events Records Reporting Research Research Personnel Research Project Grants Role Schedule System Tamoxifen Time Toxic effect Universities Vietnam Wisconsin Woman Women&apos s Group Work cost day density experience follow-up malignant breast neoplasm multidisciplinary novel programs proliferative phase Menstrual cycle sample collection size tumor

项目摘要

PROVIDED. In a randomized clinical trial of adjuvant oophorectomy and tamoxifen in 709 premenopausal Vietnamese and Chinese women with breast cancer, the proposers have demonstrated overall benefit (increased 5-year disease-free and overall survival) and specific benefit only to hormone receptor-positive tumor-bearing patients. Morbidity and symptomatic toxicity of this therapy were low; a cost-effectiveness analysis, assuming costs in Vietnam, shows a cost per life-year gained of $351. In detailed secondary analyses, benefit from adjuvant therapy was significantly greater in women undergoing simultaneous mastectomy and oophorectomy in the history-estimated luteal phases of their menstrual cycles. Analyses of axillary node-positive and younger (<= 44) patient subsets further support a novel hypothesis that adjuvant luteal phase surgical oophorectomy is more effective than this surgery performed in the follicular phase. The investigators propose a new randomized, controlled trial to investigate this hypothesis in 510 Vietnamese and Filipino premenopausal women, <= 44 years old with regular menstrual cycles and hormone receptor-positive tumors, undergoing adjuvant surgical oophorectomy followed by tamoxifen therapy. Participants will be stratified according to their likelihood of being in luteal phase of the menstrual cycle for the entire following 1-6 days, and those so unlikely will be randomized to scheduled mid-luteal phase oophorectomy or immediate oophorectomy. Blood samples for later hormonal assays will be taken on the day of oophorectomy. With accrual over 2 to 3 years and follow-up of 3 additional years, the study has 0.78-0.86 power to demonstrate disease-free survival differences which are two-thirds of those observed in the original study. The US investigators are experienced in conducting clinical trials and have proven track records for completing and publishing useful data from their work. The collaborating institutions and investigators are also clinical trial-experienced and have the patients and systems to ensure compliance with the protocol, complete pathology specimen collection and follow-up. The investigators will meet accepted and new ethical requirements for this research. A multidisciplinary data monitoring committee will oversee the study. PERFORMANCESITE(S) (organization, city, state) University of Wisconsin-Madison, Wisconsin Hospital K, National Cancer Institute, Hanoi, Viet Nam Philippine General Hospital, Manila, Philippines KEY PERSONNEL. See instructions. Use continuation pages as neededto provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Role on Project Richard R. Love University of Wisconsin-Madison Principal Investiqator Disclosure Permission Statement. Applicable to SBIR/STTROnly. See instructions. QYes [] No PHS 398 (Rev. 05101) Page Form Page 2 Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b. t PrincipInavl estigator/PrDoigreracmt(oLarst, first, middle): Love, Richard R. The name of the principalinvestigator;program director mustbe provided at the top of each printedpage and each continuation page Type density and size must conformto limits and specificationsprovided inthe PHS 398 Instructions. RESEARCH GRANT TABLE OF CONTENTS Page Numbers Face Page .............................................. 1 Description,

假如。在709年绝经前的辅助卵形切除术和他莫昔芬的随机临床试验中越南和中国乳腺癌妇女的提议者已经证明了总体好处（增加5年无病和总生存率），并且仅对激素的特定益处受体阳性肿瘤患者。这种疗法的发病率和症状毒性很低；一个假设越南成本的成本效益分析显示，每年的成本为351美元。在详细的次要分析，女性获得辅助治疗的益处明显更大在其历史估计的黄体阶段进行同时进行乳房切除术和卵巢切除术月经周期。腋窝淋巴结阳性和年轻（<= 44）患者子集的分析进一步支持一个新的假设，即佐剂佐剂期手术卵巢切除术比该手术更有效在卵泡期进行。研究人员提出了一项新的随机，对照试验，以研究510个假设越南人和菲律宾前女性，<= 44岁，有常规的月经和激素受体阳性肿瘤，进行辅助手术卵形切除术，然后是他莫昔芬治疗。参与者将根据其处于黄体阶段的可能性进行分层随后的1-6天，月经周期，这些周期不太可能被随机进行安排中腹相卵形切除术或立即进行卵巢切除术。血液样本以进行以后的荷尔蒙分析将在卵巢切除术当天进行。超过2至3年的应计，并随访3个多年来，该研究具有0.78-0.86的能力来证明无病生存差异在原始研究中观察到的三分之二。美国调查人员在进行临床试验方面经验丰富，并已验证从他们的工作中填写和发布有用的数据。合作机构和调查人员还具有经验丰富的临床试验，并拥有患者和系统以确保符合协议，完整的病理标本收集和随访。调查人员将遇到接受以及这项研究的新道德要求。多学科数据监测委员会将监督研究。表演场（S）（组织，城市，州）威斯康星州威斯康星大学麦迪逊分校越南河内国家癌症研究所K医院K 菲律宾菲律宾医院，菲律宾马尼拉关键人员。请参阅说明。根据需要使用延续页面，以下面显示的格式提供所需的信息。从首席研究员开始。按字母顺序列出所有其他关键人员，首先姓氏。姓名组织角色理查德·R·爱情大学威斯康星大学麦迪逊大学首席投资者披露许可声明。适用于Sbir/Stronly。请参阅说明。 qyes [] no PHS 398（Rev. 05101）页面2页2 整个应用程序中的底部连续数字页面。请勿使用3a，3b之类的后缀。 t princioninavl estigator/prdoigreracmt（olst，第一，中）：爱，理查德·R。主评论家的名称；计划主管必须在每个打印页面的顶部和每个延续页面上提供类型密度和大小必须符合限制和规格，并在PHS 398指令中提供。研究赠款目录页码面页............................................................................................................................................................................ 描述，