Breast Cancer Clinical Trial
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
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Women age 18 to 55 years
Regular menstrual cycles of 21- to 35-days duration
Pathologic stages I to II breast cancer, in whom all gross disease-including ductal carcinoma in situ-was surgically removed either in a one-stage or two-stage procedure.
required serum be drawn within 1 calendar day of the lumpectomy/mastectomy for women who underwent a one-stage procedure and within 1 calendar day of each stage for women who underwent a two-stage procedure.
Exclusion Criteria:
Lactation within the past 3 months
galactorrhea
neoadjuvant therapy
previous breast cancer, and history of any cancer (except squamous or basal cell skin carcinoma) in which the patient was not disease-free for at least 10 years
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There are 54 Locations for this study
Mobile Alabama, 36688, United States
Phoenix Arizona, 85006, United States
Little Rock Arkansas, 72205, United States
La Jolla California, 92037, United States
La Jolla California, 92093, United States
Hartford Connecticut, 06102, United States
Jacksonville Florida, 32207, United States
Miami Beach Florida, 33140, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Honolulu Hawaii, 96813, United States
Evanston Illinois, 60201, United States
Rockford Illinois, 61103, United States
Indianapolis Indiana, 46256, United States
Wichita Kansas, 67214, United States
Bangor Maine, 04401, United States
Baltimore Maryland, 21237, United States
Bethesda Maryland, 20892, United States
Boston Massachusetts, 02118, United States
Burlington Massachusetts, 01805, United States
Kalamazoo Michigan, 49007, United States
Minneapolis Minnesota, 55415, United States
Saint Louis Park Minnesota, 55416, United States
Keesler AFB Mississippi, 39534, United States
Kansas City Missouri, 64131, United States
Omaha Nebraska, 68114, United States
Hackensack New Jersey, 07601, United States
Newark New Jersey, 07112, United States
Syracuse New York, 13217, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44309, United States
Canton Ohio, 44710, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44122, United States
Columbus Ohio, 43206, United States
Dayton Ohio, 45429, United States
Tulsa Oklahoma, 74136, United States
Bethlehem Pennsylvania, 18015, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15236, United States
Wynnewood Pennsylvania, 19096, United States
York Pennsylvania, 17403, United States
Warwick Rhode Island, 02886, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57104, United States
Norfolk Virginia, 23507, United States
Seattle Washington, 98101, United States
Seattle Washington, 98109, United States
Tacoma Washington, 98405, United States
Parkersburg West Virginia, 26102, United States
Marshfield Wisconsin, 54449, United States
Toronto Ontario, M5B 1, Canada
Montreal Quebec, H3T 1, Canada
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