|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| 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 |
|---|
|
Breast Cancer Osteoporosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Does Tamoxifen Prevent the Skeletal and Cardiovascular Morbidity of Chemotherapy in Premenopausal Women? |
| Enrollment: | 79 |
| Study Start Date: | February 2000 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Tamoxifen group |
| Chemotherapy group |
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 |
| Sampling Method: | Non-Probability Sample |
Patients with stage I or II breast cancer currently undergoing treatment with either chemotherapy or tamoxifen.
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
| Responsible Party: | Seema Khan, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00005605 History of Changes |
| Other Study ID Numbers: | NU 95B2, NU-95B2, NCI-G00-1737 |
| Study First Received: | May 2, 2000 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
|
osteoporosis stage I breast cancer stage II breast cancer |
|
Breast Neoplasms Osteoporosis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Tamoxifen Antineoplastic Agents, Hormonal |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
