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

July 11, 2016 updated by: Alliance for Clinical Trials in Oncology

MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: blood sampling
Behavioral: patient interviewing to obtain menstrual history

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: Up to 5 years
Up to 5 years
disease-free survival
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)
NSABP Foundation Inc

Investigators

  • Study Chair: Clive S. Grant, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N9431
  • NCI-2012-02243 (Registry Identifier: CTRP (Clinical Trials Reporting System))
  • NSABP-BI-65
  • CDR0000064717 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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