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Breast CancerNCT00002762

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

An observational study of Breast Cancer and Perioperative/Postoperative Complications, run by Alliance for Clinical Trials in Oncology at 54 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 55 years, women only
What is being tested?
patient interviewing to obtain menstrual history and blood sampling
How many people
1,118 participants
Where
54 sitesin 2 countries
Study dates
Jun 1996to Oct 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

54 sites in 2 countries.

54 sites in 2 countries

United States52 sites

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Warren Grant Magnuson Clinical Center

    Bethesda, Maryland, 20892-1182

  • St. Luke's Hospital and Health Network - Bethlehem

    Bethlehem, Pennsylvania, 18015

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710-1799

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45219-0502

  • South Pointe Hospital

    Cleveland, Ohio, 44122

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Community Regional Cancer Care

    Indianapolis, Indiana, 46256

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207-8554

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2576

  • Scripps Cancer Center at Scripps Clinic

    La Jolla, California, 92037

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

    Omaha, Nebraska, 68114-4199

  • Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15236

  • Rockford Clinic

    Rockford, Illinois, 61103

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

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

    Syracuse, New York, 13217

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • Kent County Memorial Hospital

    Warwick, Rhode Island, 02886

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Wellspan Health - York Cancer Center

    York, Pennsylvania, 17403

Other trials in United States

Canada2 sites

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
patient interviewing to obtain menstrual history, blood sampling
Keywords
stage I breast cancer, stage II breast cancer, perioperative/postoperative complications
Medical subject headings
Breast Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patient interviewing to obtain menstrual historyBehavioural

  • blood samplingProcedure or surgery

Study groups in NCT00002762
Study groupRoleWhat they receive
Patient interviewing + blood samplingPatients 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.
Receives: Behavioral: patient interviewing to obtain menstrual history; Procedure: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. disease-free survival

    Measured: Up to 5 years

  2. overall survival

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 1996
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002762
Sponsor's protocol ID
NCCTG-N9431
Other IDs
NCI-2012-02243, NSABP-BI-65, CDR0000064717
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
Yes

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 Aug 1;27(22):3620-6. doi: 10.1200/JCO.2008.21.3603. Epub 2009 Jun 1.

    PubMed 19487378

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Perioperative/Postoperative Complications, run by Alliance for Clinical Trials in Oncology at 54 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease-free survival (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002762, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.

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