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 - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborators:	National Cancer Institute (NCI) National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002762

Purpose

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.

Condition	Intervention
Breast Cancer Perioperative/Postoperative Complications	Other: questionnaire administration Procedure: conventional surgery

Study Type:	Interventional
Study Design:	Treatment
Official Title:	MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menstruation Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	1100
Study Start Date:	June 1996
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002762

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Locations

United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Scripps Cancer Center at Scripps Clinic
La Jolla, California, United States, 92037
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, Florida
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207-8554
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Evanston
Evanston, Illinois, United States, 60201
Rockford Clinic
Rockford, Illinois, United States, 61103
United States, Indiana
Community Regional Cancer Care
Indianapolis, Indiana, United States, 46256
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States, 01805
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
United States, Mississippi
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nebraska
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Akron City Hospital
Akron, Ohio, United States, 44309-2090
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45219-0502
South Pointe Hospital
Cleveland, Ohio, United States, 44122
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
St. Luke's Hospital and Health Network - Bethlehem
Bethlehem, Pennsylvania, United States, 18015
Wellspan Health - York Cancer Center
York, Pennsylvania, United States, 17403
United States, Rhode Island
Kent County Memorial Hospital
Warwick, Rhode Island, United States, 02886
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Puget Sound Oncology Consortium
Seattle, Washington, United States, 98109
United States, West Virginia
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Canada, Ontario
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

National Surgical Adjuvant Breast and Bowel Project (NSABP)

Investigators

Study Chair:	Clive S. Grant, MD	Mayo Clinic
Study Chair:	D. Lawrence Wickerham, MD	Allegheny Cancer Center at Allegheny General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 Jun 1; [Epub ahead of print]

Grant CS, Hartmann LC, Suman VJ, et al.: Menstrual cycle and surgical treatment of breast cancer: findings from the NCCTG N9431 study. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-5088, 2004.

Study ID Numbers:	CDR0000064717, NCCTG-N9431, NSABP-BI-65
Study First Received:	November 1, 1999
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00002762 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
perioperative/postoperative complications

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases

Postoperative Complications
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009