Expired Study
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Chicago, Illinois 60611


Purpose:

RATIONALE: Tamoxifen may be able to increase bone density and decrease cholesterol in women who are undergoing chemotherapy for breast cancer. PURPOSE: Clinical trial to study the effectiveness of tamoxifen in preventing bone loss and heart disease caused by chemotherapy treatment in premenopausal women who have stage I or stage II breast cancer.


Study summary:

OBJECTIVES: - Compare the bone density in the femoral neck and lumbar spine and cholesterol levels in premenopausal women with stage I or II breast cancer treated with adjuvant chemotherapy with or without tamoxifen. - Collect information regarding breast cancer risk factors, treatment, pathology, diet, activity levels, weight, and smoking in these patients. OUTLINE: Patients are stratified according to type of treatment (adjuvant chemotherapy plus tamoxifen vs adjuvant chemotherapy alone). Patients receive adjuvant chemotherapy with or without oral tamoxifen at the discretion of the treating physician. Prior to starting chemotherapy, patients undergo blood draw to measure baseline levels of follicle-stimulating hormone, estradiol, total cholesterol, high-density lipoproteins, and low-density lipoproteins. Patients undergo baseline bone densitometry of the femoral neck and lumbar spine to assess bone density prior to starting chemotherapy or within 30 days of the first drug treatment. Laboratory studies and bone densitometry are repeated at years 1 and 2. A comparison is made between the study findings at baseline and at years 1 and 2. PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven stage I or II breast cancer - Must be scheduled to receive adjuvant chemotherapy with or without tamoxifen - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 35 to 50 Sex: - Female Menopausal status: - Premenopausal by follicle-stimulating hormone and estradiol levels Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - See Disease characteristics Radiotherapy: - Not specified Surgery: - Not specified


NCT ID:

NCT00005605


Primary Contact:

Study Chair
Seema A. Khan, MD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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