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Home > "T" Clinical Trials Conditions > Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer  Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer
Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer
For Condition: stage 2 breast cancer,stage 1 breast cancer,Osteoporosis
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 35 Years/50 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MonicaMorrow, Study Chair, Northwestern Memorial Hospital
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Monica Morrow 312-926-9039
Additional Information:
Study ID Numbers: CDR0000067728; NCI-G00-1737,NU-95B2
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005605
Other Stage 1 Breast Cancer Studies:
1. Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed
2. Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
3. Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer
4. Clodronate With or Without Chemotherapy and/or Tamoxifen in Treating Women With Stage I or Stage II Breast Cancer
5. Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
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Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer
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