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
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.
Other: questionnaire administration
Procedure: conventional surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER|
|Study Start Date:||June 1996|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002762
Show 54 Study Locations
|Study Chair:||Clive S. Grant, MD||Mayo Clinic|
|Study Chair:||D. Lawrence Wickerham, MD||Allegheny Cancer Center at Allegheny General Hospital|