Luteal Adjuvant Oophorectomy in Vietnamese Breast Cancer

黄体辅助卵巢切除术治疗越南乳腺癌

• 批准号: 7122391
• 负责人: Richard Reed Love
• 金额: $ 56万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-03-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7122391
• 关键词: Asians; Philippines; breast neoplasms; clinical research; clinical trials; combination cancer therapy; disease /therapy duration; female; hormone receptor; hormone related neoplasm /cancer; human subject; human therapy evaluation; longitudinal human study; menstrual cycle; neoplasm /cancer surgery; outcomes research; ovariectomy; patient oriented research; prognosis; southeast Asia; tamoxifen; women' s health

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：在709例月果越越南和中国乳腺癌妇女的辅助卵形切除术和他莫昔芬的随机临床试验中，这些提案者已经证明了总体益处（增加了5年的无病和整体生存），并且仅对激素受体受体效果肿瘤患者有特定的益处。这种疗法的发病率和症状毒性很低；假设越南成本的成本效益分析显示，每年的成本为351美元。在详细的次要分析中，在同时乳房切除术和卵巢切除术中，辅助治疗的益处明显更大，在其月经周期的历史估计的黄体阶段中。腋窝淋巴结阳性和年轻（<= 44）患者子集的分析进一步支持了一种新的假设，即辅助黄体期手术卵巢切除术比在卵泡相中进行的手术更有效。 研究人员提出了一项新的随机，对照试验，以研究510名越南和菲律宾前女性妇女中的这一假设，<= 44岁，患有常规的月经周期和激素受体阳性肿瘤，进行了辅助手术杀菌术，然后接受他莫昔芬治疗。参与者将根据其在整个1-6天内处于月经周期的黄体阶段的可能性进行分层，而这些阶段的可能性不太可能将其随机分配给定期的中腹相卵形切除术或立即卵巢切除术。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。该研究具有超过2至3年的应计2至3年的随访，具有0.78-0.86的能力，可证明无病生存差异，这是原始研究中观察到的无病生存差异。美国调查人员经验丰富，在进行临床试验方面经验丰富，并已验证了从其工作中填写和发布有用数据的记录。合作的机构和研究人员也具有临床试验经验，并拥有患者和系统以确保符合方案，完整的病理标本收集和随访。调查人员将满足这项研究的公认和新的道德要求。多学科数据监测委员会将监督这项研究。