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| Sponsors and Collaborators: |
North Central Cancer Treatment Group 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 |
Procedure: conventional surgery Procedure: management of therapy complications |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Menstruation |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | MENSTRUAL CYCLE AND SURGICAL TREATMENT OF BREAST CANCER |
| Estimated Enrollment: | 1100 |
| Study Start Date: | June 1996 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations![]() |
Show 54 Study Locations |
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| Study Chair: | Clive S. Grant, MD | Mayo Clinic |
| Study Chair: | D. Lawrence Wickerham, MD | Allegheny Cancer Center at Allegheny General Hospital |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| 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 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002762 |
| Health Authority: | United States: Federal Government |
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