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| ID | Type | Description | Link |
|---|---|---|---|
| NU-95B2 | |||
| NCI-G00-1737 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen group | |||
| Chemotherapy group |
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DISEASE CHARACTERISTICS:
Histologically proven stage I or II breast cancer
Must be scheduled to receive adjuvant chemotherapy with or without tamoxifen
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:
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Patients with stage I or II breast cancer currently undergoing treatment with either chemotherapy or tamoxifen.
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| Name | Affiliation | Role |
|---|---|---|
| Seema A. Khan, MD | Robert H. Lurie Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |