Luteal adjuvant oophorectomy in asian breast cancer

黄体辅助卵巢切除术治疗亚洲乳腺癌

• 批准号: 8020124
• 负责人: Richard Reed Love
• 金额: $ 59.46万
• 依托单位: INTERNATIONAL BREAST CANCER RESEARCH FDN
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-01 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8020124
• 关键词: Adjuvant; Adjuvant Therapy; Asians; Benign; Bilateral oophorectomy; Biological Assay; Biological Markers; Blood; Blood specimen; Breast Cancer Treatment; Case Study; Corpus Luteum Cyst; Disease-Free Survival; Enrollment; Estradiol; Filipino; Frequencies; Goals; Health; Hormonal; Hormone Receptor; Hormones; Length; Luteal Phase; Luteinizing Hormone; Mammary Gland Parenchyma; Mastectomy; Menstrual cycle; Modified radical mastectomy; Operative Surgical Procedures; Ovariectomy; Ovary; Participant; Pathologic; Patients; Phase; Premenopause; Progesterone; Progesterone Receptors; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Reporting; Research; Research Personnel; Schedule; Solid Neoplasm; Tamoxifen; Testing; Time; Woman; Work; base; disorder control; estrophilin; experience; follow-up; hazard; improved; malignant breast neoplasm; novel; proliferative phase Menstrual cycle; receptor; tumor

DESCRIPTION (provided by applicant): In two exploratory analyses with short (median 3.5 years) and longer (median 7.0 years) follow-up of women with operable breast cancer treated with adjuvant surgical oophorectomy, the proposers found that benefit from adjuvant therapy was significantly greater in women undergoing simultaneous mastectomy and oophorectomy in the history-estimated luteal phases of their menstrual cycles. The investigators have been conducting a randomized, controlled trial to investigate the hypothesis that luteal phase oophorectomy is superior to follicular phase surgery in Filipino, Vietnamese or Moroccan premenopausal women with regular menstrual cycles and hormone receptor-positive tumors, undergoing adjuvant surgical oophorectomy followed by tamoxifen therapy. Blood samples for hormonal assays are taken on the day of oophorectomy for later analysis. As of June 1, 2008, 548 women have been enrolled in the trial. Based on recent experience, the accrual goal of 762 will be reached by June 2009. Compliance with randomized assignments for dates of surgery has been good and less than 1% of cases have been lost to follow-up. With follow-up of 3.5 years from the time of last study case entry, (to December 31, 2012), the study is expected to have at least 80% power to detect a hazard ratio for disease-free survival of 0.65 comparing mid-luteal phase scheduled and immediate ophorectomy/mastectomy surgery. Four years of support is requested to complete this novel hypothesis-testing trial. PUBLIC HEALTH RELEVANCE: The goal of the study is to prove that we can improve the survival of the average (middle) woman in the trial by a year with luteal phase oophorectomy. 548 women have entered the study so far. We will also study other aspects of these treatments including how long they work in controlling the disease, and the relationships of progesterone and other hormone levels on the day of oophorectomy surgery to disease free survival. If the improvement in treatment tested works, this will have major implications for treatment of breast cancer and other solid tumors generally.

描述（由申请人提供）：在两项探索性分析中（中位3。5年）和更长的（中位数7.0岁）对接受辅助手术性卵巢切除术治疗的可手术乳腺癌的妇女随访，该建议者发现，在经历同时进行术的术语和植物术的女性中，辅助治疗中的辅助治疗较大。研究人员一直在进行一项随机，对照试验，以研究以下假设：在菲律宾，越南语或摩洛哥摩洛哥前妇女中，具有常规的月经周期和激素受体受体阳性肿瘤，经过辅助外科手术术经过tamamoxifen thamexifen thamefifen thamoxifen thamefiff themoxifen。在卵巢切除术当天进行荷尔蒙测定的血液样本，以供以后分析。截至2008年6月1日，已入学548名妇女。根据最近的经验，到2009年6月，将达到762的应计目标。遵守手术日期的随机任务是好的，不到1％的病例因随访而丢失。从上次研究案例进入后3。5年（到2012年12月31日），该研究预计至少具有80％的功率来检测0.65的危害比，比较了腹腔中期期和直接肠道切除术/乳房切除术手术的危险比。要求提供四年的支持以完成这项新的假设检验试验。公共卫生相关性：该研究的目的是证明我们可以通过一年在黄体期卵巢切除术中提高试验中平均（中）女性的生存。到目前为止，有548名妇女已经进入了这项研究。我们还将研究这些治疗方法的其他方面，包括它们在控制该疾病方面的工作时间，以及在卵巢切除术手术当天与疾病无生存期的孕酮和其他激素水平的关系。如果经过治疗的作品的改善，这将对乳腺癌和其他实体瘤的治疗产生重大影响。