Timing of Menstrual Cycle and Surgery in Treating Premenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
Timing of Menstrual Cycle and Surgery in Treating Premenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
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.
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.

 Patients complete a 30-minute telephone interview regarding medical, family, occupational,
 and reproductive history and lifestyle habits (e.g., diet, exercise, or environmental
 exposures). Beginning 24 hours prior to surgery and continuing until the onset of the next
 menses, patients complete a menstrual cycle journal indicating the start and length of
 menses.

 Patients undergoing mastectomy are followed every 3 months for 1 year, every 6 months for 1
 year, and then annually thereafter. Patients undergoing adjuvant therapy are followed every 3
 months for 3 years and then every 6 months thereafter or every 4 months for 2 years and then
 every 6 months thereafter.

 PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study within 2.5
 years.
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:

 Age:

 -  Premenopausal

 Sex:

 -  Female

 Menopausal status:

 -  See Disease Characteristics

 Performance status:

 -  Not specified

 Life expectancy:

 -  Not specified

 Hematopoietic:

 -  Not specified

 Hepatic:

 -  Not specified

 Renal:

 -  Not specified

 Other:

 -  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

 Surgery:

 -  See Disease Characteristics

 -  No prior hysterectomy and/or bilateral oophorectomy