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
- Conditions
- Breast CancerPerioperative/Postoperative Complications
- Interventions
- Behavioral: patient interviewing to obtain menstrual historyProcedure: blood sampling
- Registration Number
- NCT00002762
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1118
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient interviewing + blood sampling 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 + blood sampling patient interviewing to obtain menstrual history 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.
- Primary Outcome Measures
Name Time Method overall survival Up to 5 years disease-free survival Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (54)
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Rockford Clinic
🇺🇸Rockford, Illinois, United States
Scripps Cancer Center at Scripps Clinic
🇺🇸La Jolla, California, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Baptist Regional Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Community Regional Cancer Care
🇺🇸Indianapolis, Indiana, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, 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
Keesler Medical Center - Keesler Air Force Base
🇺🇸Keesler AFB, Mississippi, 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
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
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
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
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Warren Grant Magnuson Clinical Center
🇺🇸Bethesda, Maryland, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, 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
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States