MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER
18 Years
55 Years
Female
Breast Cancer, Perioperative/Postoperative Complications
Trial Information
MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER
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.
OUTLINE: This is a multicenter study.
Hormone levels and menstrual history are obtained within one calendar day to surgery.
Patients undergo either one- or two-stage surgery (open biopsy followed immediately or later
by mastectomy or breast-conserving surgery).
Patients complete a questionnaire 6 months after surgery to assess the extent of adjuvant
therapy received (if any) and a questionnaire 12 months after surgery to assess recurrence
of breast cancer and vital status.
Patients are followed annually for 10 years.
PROJECTED ACCRUAL: A total of 1,100 patients will be accrued for this study within 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage I or II breast cancer
- No prior breast cancer
- Must have regular menstrual cycles (21-35 days)
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 to 55
Sex:
- Female
Menopausal status:
- Premenopausal
Performance status:
- Not specified
Life expectancy:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant
- No nursing within the past 3 months
- No galactorrhea
- No prior malignancy within the past 10 years except squamous cell or basal cell skin
cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Concurrent chemotherapy allowed
Endocrine therapy:
- At least 3 months since prior oral contraceptives
Radiotherapy:
- Concurrent radiotherapy allowed
Surgery:
- Complete surgical resection required prior to entry
- One- or two-stage procedure (e.g., open biopsy followed immediately or later by
mastectomy or breast-conserving approach)
- Two-step registration required for patients undergoing two-stage procedure
- Fine-needle aspiration (FNA), stereotactic, or core-needle biopsy is allowed at any
time prior to open biopsy
- Sentinel node dissection/axillary node dissection allowed
Other:
- No prior neoadjuvant therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Clive S. Grant, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000064717
NCT ID:
NCT00002762
Start Date:
June 1996
Completion Date:
Related Keywords:
- Breast Cancer
- Perioperative/Postoperative Complications
- stage I breast cancer
- stage II breast cancer
- perioperative/postoperative complications
- Breast Neoplasms
- Postoperative Complications
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| CCOP - Evanston | Evanston, Illinois 60201 |
| Keesler Medical Center - Keesler Air Force Base | Keesler AFB, Mississippi 39534-2576 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Baptist Regional Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Puget Sound Oncology Consortium | Seattle, Washington 98109 |
| Hartford Hospital | Hartford, Connecticut 06102-5037 |
| Rockford Clinic | Rockford, Illinois 61103 |
| Eastern Maine Medical Center | Bangor, Maine 04401 |
| Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| South Pointe Hospital | Cleveland, Ohio 44122 |
| CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
| Kent County Memorial Hospital | Warwick, Rhode Island 02886 |
| Eastern Virginia Medical School | Norfolk, Virginia 23507 |
| Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| Community Regional Cancer Care | Indianapolis, Indiana 46219 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Scripps Cancer Center at Scripps Clinic | La Jolla, California 92037 |
| Warren Grant Magnuson Clinical Center | Bethesda, Maryland 20892-1182 |
| Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
| St. Luke's Hospital and Health Network - Bethlehem | Bethlehem, Pennsylvania 18015 |
| Wellspan Health - York Cancer Center | York, Pennsylvania 17403 |
| CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
