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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Correlation of Menstrual Cycle Phase at the Time of Surgery With Disease-Free Survival in Premenopausal Women With Stage I or 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

Trial Description

Purpose:

Timing of breast cancer surgery may improve effectiveness of treatment and may help patients live longer.

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.

Eligibility:

• 18-55 years old
• At least 3 months since oral contraceptives
• Must have regular menstrual periods between 21 and 35 days apart
• No previous breast cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Hormone levels and menstrual history will be obtained. Patients will then undergo surgery. They will complete a questionnaire at 6 months and 1 year after surgery. Patients will be evaluated once a year for 10 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

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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