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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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002762
First received: November 1, 1999
Last updated: October 13, 2009
Last verified: October 2009
History of Changes
  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: Primary Purpose: Treatment
Official Title: MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

Resource links provided by NLM:

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

  Show 54 Study Locations
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, 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.

ClinicalTrials.gov Identifier: NCT00002762     History of Changes
Other Study ID Numbers: CDR0000064717, NCCTG-N9431, NSABP-BI-65
Study First Received: November 1, 1999
Last Updated: October 13, 2009
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:
Breast Neoplasms
Postoperative Complications
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013