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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005079 |
RATIONALE: The timing of breast cancer surgery within the menstrual cycle may affect outcome. It is not yet known if treatment is more effective during the initial or final phase of the menstrual cycle.
PURPOSE: Phase III trial to determine the effect of menstrual cycle phase at surgery in treating premenopausal women who have stage I, stage II, or stage III breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: conventional surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis |
Study Start Date: | January 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo either fine needle aspiration concurrently with definitive breast surgery (mastectomy or lumpectomy) or needle-directed excisional biopsy followed by definitive breast surgery.
Patients undergo serum collection for hormonal analysis preoperatively, 24 hours post operatively, at days 7 and 14, and at 3 months and urine collection for hormonal analysis beginning 24 hours prior to surgery and continuing daily until the onset of the next menses.
Patients complete a 30-minute telephone interview regarding medical, family, occupational, and reproductive history and lifestyle habits (e.g., diet, exercise, or environmental exposures). Beginning 24 hours prior to surgery and continuing until the onset of the next menses, patients complete a menstrual cycle journal indicating the start and length of menses.
Patients undergoing mastectomy are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. Patients undergoing adjuvant therapy are followed every 3 months for 3 years and then every 6 months thereafter or every 4 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study within 2.5 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage I, II, or III primary breast cancer undergoing breast surgery
Premenopausal
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
Rebecca and John Moores UCSD Cancer Center | |
La Jolla, California, United States, 92093-0658 |
Study Chair: | Helena R. Chang, MD, PhD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067686, UCLA-9810046, UCSD-985772, NCI-G00-1724 |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005079 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |