Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
RATIONALE: The timing of breast cancer surgery within the menstrual cycle may affect outcome. It is not yet known if treatment is more effective during the initial or final phase of the menstrual cycle.
PURPOSE: Phase III trial to determine the effect of menstrual cycle phase at surgery in treating premenopausal women who have stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
- Determine if the timing of breast surgery during the menstrual cycle impacts disease recurrence, progression, or death among different racial groups in premenopausal women with stage I, II, or III breast cancer.
- Determine if definitive breast cancer surgeries (e.g., lumpectomy or mastectomy) performed during the follicular phase result in poorer prognosis (recurrence, disease progression, or death) compared with surgeries performed during the midcycle or luteal phases in this patient population.
OUTLINE: This is a multicenter study.
Patients undergo either fine needle aspiration concurrently with definitive breast surgery (mastectomy or lumpectomy) or needle-directed excisional biopsy followed by definitive breast surgery.
Patients undergo serum collection for hormonal analysis preoperatively, 24 hours post operatively, at days 7 and 14, and at 3 months and urine collection for hormonal analysis beginning 24 hours prior to surgery and continuing daily until the onset of the next menses.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage I, II, or III primary breast cancer undergoing breast surgery
- •Invasive disease (e.g., lobular or ductal)
- •No bilateral disease
- •No distant metastases
- •Premenopausal
- •Regular menses (no amenorrhea of more than 90 days) without hormone replacement
- •Documented last menstrual period
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Premenopausal
- •Menopausal status:
- •See Disease Characteristics
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No other prior malignancies
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No preoperative chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal replacement therapy
- •No concurrent interruptive oral contraceptive use of less than 3 months
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •No prior hysterectomy and/or bilateral oophorectomy
排除标准
- 未提供