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
NCT ID: NCT00002762
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1118 participants
OBSERVATIONAL
1996-06-30
2009-10-31
Brief Summary
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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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Detailed Description
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* 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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
patient interviewing to obtain menstrual history
blood sampling
Interventions
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patient interviewing to obtain menstrual history
blood sampling
Eligibility Criteria
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Inclusion Criteria
2. Regular menstrual cycles of 21- to 35-days duration
3. 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.
4. 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
2. galactorrhea
3. neoadjuvant therapy
4. 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
18 Years
55 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Clive S. Grant, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Scripps Cancer Center at Scripps Clinic
La Jolla, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
CCOP - Evanston
Evanston, Illinois, United States
Rockford Clinic
Rockford, Illinois, United States
Community Regional Cancer Care
Indianapolis, Indiana, United States
CCOP - Wichita
Wichita, Kansas, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
South Pointe Hospital
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
St. Luke's Hospital and Health Network - Bethlehem
Bethlehem, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Wellspan Health - York Cancer Center
York, Pennsylvania, United States
Kent County Memorial Hospital
Warwick, Rhode Island, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Puget Sound Oncology Consortium
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Jewish General Hospital - Montreal
Montreal, Quebec, Canada
Countries
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References
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Grant CS, Ingle JN, Suman VJ, Dumesic DA, Wickerham DL, Gelber RD, Flynn PJ, Weir LM, Intra M, Jones WO, Perez EA, Hartmann LC. Menstrual cycle and surgical treatment of breast cancer: findings from the NCCTG N9431 study. J Clin Oncol. 2009 Aug 1;27(22):3620-6. doi: 10.1200/JCO.2008.21.3603. Epub 2009 Jun 1.
Other Identifiers
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NCI-2012-02243
Identifier Type: REGISTRY
Identifier Source: secondary_id
NSABP-BI-65
Identifier Type: -
Identifier Source: secondary_id
CDR0000064717
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N9431
Identifier Type: -
Identifier Source: org_study_id
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