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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

1118

Study ID:

NCT00002762

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 54 Locations for this study

See Locations Near You

MBCCOP - Gulf Coast
Mobile Alabama, 36688, United States
CCOP - Western Regional, Arizona
Phoenix Arizona, 85006, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Scripps Cancer Center at Scripps Clinic
La Jolla California, 92037, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
Rockford Clinic
Rockford Illinois, 61103, United States
Community Regional Cancer Care
Indianapolis Indiana, 46256, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Franklin Square Hospital Center
Baltimore Maryland, 21237, United States
Warren Grant Magnuson Clinical Center
Bethesda Maryland, 20892, United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts, 02118, United States
Lahey Clinic Medical Center - Burlington
Burlington Massachusetts, 01805, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Keesler Medical Center - Keesler Air Force Base
Keesler AFB Mississippi, 39534, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha Nebraska, 68114, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13217, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Akron City Hospital
Akron Ohio, 44309, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton Ohio, 44710, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45219, United States
South Pointe Hospital
Cleveland Ohio, 44122, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
CCOP - Oklahoma
Tulsa Oklahoma, 74136, United States
St. Luke's Hospital and Health Network - Bethlehem
Bethlehem Pennsylvania, 18015, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15236, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
Wellspan Health - York Cancer Center
York Pennsylvania, 17403, United States
Kent County Memorial Hospital
Warwick Rhode Island, 02886, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
Eastern Virginia Medical School
Norfolk Virginia, 23507, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Puget Sound Oncology Consortium
Seattle Washington, 98109, United States
CCOP - Northwest
Tacoma Washington, 98405, United States
Camden-Clark Memorial Hospital
Parkersburg West Virginia, 26102, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield Wisconsin, 54449, United States
St. Michael's Hospital - Toronto
Toronto Ontario, M5B 1, Canada
Jewish General Hospital - Montreal
Montreal Quebec, H3T 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1118

Study ID:

NCT00002762

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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