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临床试验/NCT00002762
NCT00002762已完成不适用

MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

Alliance for Clinical Trials in Oncology54 个研究点 分布在 1 个国家目标入组 1,118 人开始时间: 1996年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,118
试验地点
54
主要终点
overall survival

研究概览

简要总结

RATIONALE: Timing of breast cancer surgery may improve effectiveness of treatment and may help patients live longer.

PURPOSE: Clinical trial to determine whether timing of primary surgery in relation to menstrual cycle is associated with disease-free survival 5 years after surgery in women who have stage I or stage II breast cancer.

详细描述

OBJECTIVES:

  • Document menstrual phase (follicular vs luteal) by circulating hormones and menstrual history at the time of primary surgery in premenopausal women with stage I or II breast cancer.
  • Correlate menstrual phase at primary surgery with 5-year disease-free survival in these patients.
  • Compare the menstrual cycle data obtained by hormone levels and study-specific menstrual cycle history with information recorded in the general written record.
  • Compare the menstrual cycle data (e.g., hormone levels and cycle history) for these women with the data for the general population.
  • Estimate the disease-free survival of women who undergo a 2-stage surgical procedure with cancer found at both stages when the surgery is not confined to the same menstrual cycle phase.

Premenopausal women age 18 to 55 years, who were interviewed for menstrual history and who were surgically treated for stages I to II breast cancer, had serum drawn within 1 day of surgery for estradiol, progesterone, and luteinizing hormone levels. Menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. Disease-free survival (DFS) and overall survival (OS) rates were determined by Kaplan-Meier method and were compared by using the log-rank test and Cox proportional hazard modeling.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women age 18 to 55 years
  • Regular menstrual cycles of 21- to 35-days duration
  • Pathologic stages I to II breast cancer, in whom all gross disease-including ductal carcinoma in situ-was surgically removed either in a one-stage or two-stage procedure.
  • required serum be drawn within 1 calendar day of the lumpectomy/mastectomy for women who underwent a one-stage procedure and within 1 calendar day of each stage for women who underwent a two-stage procedure.

排除标准

  • Lactation within the past 3 months
  • galactorrhea
  • neoadjuvant therapy
  • previous breast cancer, and history of any cancer (except squamous or basal cell skin carcinoma) in which the patient was not disease-free for at least 10 years

结局指标

主要结局

overall survival

时间窗: Up to 5 years

disease-free survival

时间窗: Up to 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (54)

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