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| Sponsor: | Robert H. Lurie Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005605 |
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Osteoporosis |
Drug: tamoxifen citrate |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | Does Tamoxifen Prevent the Skeletal and Cardiovascular Morbidity of Chemotherapy in Premenopausal Women? |
| Study Start Date: | February 2000 |
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.
Eligibility| Ages Eligible for Study: | 35 Years to 50 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:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Seema A. Khan, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000067728, NU-95B2, NCI-G00-1737 |
| Study First Received: | May 2, 2000 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005605 History of Changes |
| Health Authority: | United States: Federal Government |
|
osteoporosis stage I breast cancer stage II breast cancer |
|
Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic |
Selective Estrogen Receptor Modulators Bone Diseases Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Musculoskeletal Diseases Therapeutic Uses Breast Diseases |
