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

NCT00002762 | Completed DMC

• 4 other identifiers: NCCTG-N9431NCI-2012-02243NSABP-BI-65CDR0000064717
• Study Type: observational
• Target: 1,118
• Locations: 2 countries
• Sites: 54

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.

Conditions

Breast Cancer; Perioperative/Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (2)

• disease-free survival

  Up to 5 years

• overall survival

  Up to 5 years

Study Arms (1)

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.

Behavioral: patient interviewing to obtain menstrual history; Procedure: blood sampling

Interventions

patient interviewing to obtain menstrual history BEHAVIORAL

Patient interviewing + blood sampling

blood sampling PROCEDURE

Patient interviewing + blood sampling

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This trial enrolled premenopausal women age 18 to 55 years who had regular menstrual cycles of 21- to 35-days duration and 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator
• NSABP Foundation Inc: collaborator

Study Sites (54)

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Scripps Cancer Center at Scripps Clinic

La Jolla, California, 92037, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, 32207-8554, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

Rockford Clinic

Rockford, Illinois, 61103, United States

Location

Community Regional Cancer Care

Indianapolis, Indiana, 46256, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Warren Grant Magnuson Clinical Center

Bethesda, Maryland, 20892-1182, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, 01805, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Keesler Medical Center - Keesler Air Force Base

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Aultman Hospital Cancer Center at Aultman Health Foundation

Canton, Ohio, 44710-1799, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45219-0502, United States

Location

South Pointe Hospital

Cleveland, Ohio, 44122, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

St. Luke's Hospital and Health Network - Bethlehem

Bethlehem, Pennsylvania, 18015, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15236, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Wellspan Health - York Cancer Center

York, Pennsylvania, 17403, United States

Location

Kent County Memorial Hospital

Warwick, Rhode Island, 02886, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Camden-Clark Memorial Hospital

Parkersburg, West Virginia, 26102, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• 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.

  PMID: 19487378 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Postoperative Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Clive S. Grant, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: June 1, 1996
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

CA (2); US (52)