Trial Information

Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis

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.