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.

OUTLINE: This is a multicenter study.

Hormone levels and menstrual history are obtained within one calendar day to surgery.

Patients undergo either one- or two-stage surgery (open biopsy followed immediately or later by mastectomy or breast-conserving surgery).

Patients complete a questionnaire 6 months after surgery to assess the extent of adjuvant therapy received (if any) and a questionnaire 12 months after surgery to assess recurrence of breast cancer and vital status.

Patients are followed annually for 10 years.

PROJECTED ACCRUAL: A total of 1,100 patients will be accrued for this study within 5 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed stage I or II breast cancer
• No prior breast cancer
• Must have regular menstrual cycles (21-35 days)

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 to 55

Sex:

• Female

Menopausal status:

• Premenopausal

Performance status:

• Not specified

Life expectancy:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant
• No nursing within the past 3 months
• No galactorrhea
• No prior malignancy within the past 10 years except squamous cell or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Concurrent chemotherapy allowed

Endocrine therapy:

• At least 3 months since prior oral contraceptives

Radiotherapy:

• Concurrent radiotherapy allowed

Surgery:

• Complete surgical resection required prior to entry
• One- or two-stage procedure (e.g., open biopsy followed immediately or later by mastectomy or breast-conserving approach)
• Two-step registration required for patients undergoing two-stage procedure
• Fine-needle aspiration (FNA), stereotactic, or core-needle biopsy is allowed at any time prior to open biopsy
• Sentinel node dissection/axillary node dissection allowed

Other:

• No prior neoadjuvant therapy