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 - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborators:	National Cancer Institute (NCI) National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002762

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:	Treatment
Official Title:	MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menstruation Surgery

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, 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 Jun 1; [Epub ahead of print]

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.

Study ID Numbers:	CDR0000064717, NCCTG-N9431, NSABP-BI-65
Study First Received:	November 1, 1999
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00002762 History of Changes
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:

Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases

Postoperative Complications
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009