Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Natural history/Epidemiology, Treatment	Completed	18 to 55	NCI	NCCTG-N9431 NSABP-BI-65, NCT00002762, N9431

Objectives

1. 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.
2. Correlate menstrual phase at primary surgery with 5-year disease-free survival in these patients.
3. Compare the menstrual cycle data obtained by hormone levels and study-specific menstrual cycle history with information recorded in the general written record.
4. Compare the menstrual cycle data (e.g., hormone levels and cycle history) for these women with the data for the general population.
5. 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.

Entry 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

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

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

Expected Enrollment

A total of 1,100 patients will be accrued for this study within 5 years.

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.

Grant CS, Ingle JN, Suman VJ, et al.: Menstrual cycle and surgical treatment of breast cancer: findings from the NCCTG N9431 study. J Clin Oncol 27 (22): 3620-6, 2009.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Clive Grant, MD, Protocol chair		Ph: 507-284-2644 Email: cgrant@mayo.edu

National Surgical Adjuvant Breast and Bowel Project

D. Lawrence Wickerham, MD, Protocol chair		Ph: 412-359-3336; 866-680-0004

Registry Information
Official Title		MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER
Trial Start Date		1996-06-14
Trial Completion Date		2009-10-09
Registered in ClinicalTrials.gov		NCT00002762
Date Submitted to PDQ		1996-06-14
Information Last Verified		2009-10-09
NCI Grant/Contract Number		CA25224

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