NCT00002762

Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer

MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,118 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
BEHAVIORAL	patient interviewing to obtain menstrual history
PROCEDURE	blood sampling

Timeline

• Start date: 1996-06-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2003-01-27
• Last updated: 2016-07-12

Locations

54 sites across 2 countries: United States, Canada