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
|ClinicalTrials.gov Identifier: NCT00002762|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 12, 2016
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Perioperative/Postoperative Complications||Behavioral: patient interviewing to obtain menstrual history Procedure: blood sampling|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||1118 participants|
|Official Title:||MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER|
|Study Start Date :||June 1996|
|Primary Completion Date :||October 2009|
|Study Completion Date :||October 2009|
Patient interviewing + blood sampling
Patients were interviewed at the time of the primary cancer surgery to determine the menstrual history. Blood sampling occurred within 1 day of surgery, and serum samples were shipped frozen to a central laboratory (Mayo Medical Laboratory, Rochester, MN) for E2, Pg, and LH determinations. Serum hormone levels, menstrual cycle length, and day of last menses were used to determine the menstrual phase at which surgery occurred.
Patients were observed every 6 months for the first year postregistration and annually for the next 2 to 10 years postregistration for adjuvant therapy information, disease recurrence, and death.
|Behavioral: patient interviewing to obtain menstrual history Procedure: blood sampling|
- disease-free survival [ Time Frame: Up to 5 years ]
- overall survival [ Time Frame: Up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002762
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|Study Chair:||Clive S. Grant, MD||Mayo Clinic|