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

Tracking Information

First Received Date ^ICMJE

May 2, 2000

Last Updated Date

May 9, 2009

Start Date ^ICMJE

February 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00005605 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

Breast Cancer
Osteoporosis

Intervention ^ICMJE

Drug: tamoxifen citrate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

35 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00005605

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067728, NU-95B2, NCI-G00-1737

Study Sponsor ^ICMJE

Robert H. Lurie Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Seema A. Khan, MD

Robert H. Lurie Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP