Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
NSABP Foundation Inc
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: October 13, 2009
Last verified: October 2009

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

Resource links provided by NLM:

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:


  • 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.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 55


  • Female

Menopausal status:

  • Premenopausal

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


  • Concurrent chemotherapy allowed

Endocrine therapy:

  • At least 3 months since prior oral contraceptives


  • Concurrent radiotherapy allowed


  • 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


  • No prior neoadjuvant therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002762

  Show 54 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
NSABP Foundation Inc
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:
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. 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
Breast Diseases
Neoplasms by Site
Pathologic Processes
Skin Diseases processed this record on November 20, 2014