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

Breast Cancer Clinical Trial

Official title:

MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002762
• Other study ID #: NCCTG-N9431
• Secondary ID: NCI-2012-02243NS
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: July 11, 2016
• Start date: June 1996
• Est. completion date: October 2009

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: NCI Central Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1118
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Women age 18 to 55 years

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:

1. Lactation within the past 3 months

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Behavioral:
• patient interviewing to obtain menstrual history

Procedure:
• blood sampling

Locations

Country	Name	City	State
Canada	Jewish General Hospital - Montreal	Montreal	Quebec
Canada	St. Michael's Hospital - Toronto	Toronto	Ontario
United States	Akron City Hospital	Akron	Ohio
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Warren Grant Magnuson Clinical Center	Bethesda	Maryland
United States	St. Luke's Hospital and Health Network - Bethlehem	Bethlehem	Pennsylvania
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts
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 - Evanston	Evanston	Illinois
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Community Regional Cancer Care	Indianapolis	Indiana
United States	Baptist Regional Cancer Institute - Jacksonville	Jacksonville	Florida
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler Air Force Base	Keesler AFB	Mississippi
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	Scripps Cancer Center at Scripps Clinic	La Jolla	California
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Rockford Clinic	Rockford	Illinois
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Puget Sound Oncology Consortium	Seattle	Washington
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	Kent County Memorial Hospital	Warwick	Rhode Island
United States	CCOP - Wichita	Wichita	Kansas
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	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	Wellspan Health - York Cancer Center	York	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI), NSABP Foundation Inc

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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.

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):3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		Up to 5 years	No
Primary	overall survival		Up to 5 years	No