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Study of Tamoxifen in the Prevention of Skeletal and Cardiovascular Morbidity Associated With Adjuvant Chemotherapy in Premenopausal Women With Stage I or II Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified

Supportive care

Closed

35 to 50

NCI

NU-95B2
NCI-G00-1737, NCT00005605

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.

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

Prior/Concurrent Therapy:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

See Disease characteristics

Radiotherapy:

Not specified

Surgery:

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

Expected Enrollment

A total of 80 patients (40 per stratum) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Seema Khan, MD, Protocol chair
Ph: 312-503-2112
Email: skhan@nmff.org

Registry Information

Official Title		Does Tamoxifen Prevent the Skeletal and Cardiovascular Morbidity of Chemotherapy in Premenopausal Women?

Trial Start Date		2000-02-11

Registered in ClinicalTrials.gov		NCT00005605

Date Submitted to PDQ		2000-03-03

Information Last Verified		2004-04-08

NCI Grant/Contract Number		P30-CA60553

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.