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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00005605
First received: May 2, 2000
Last updated: February 18, 2011
Last verified: February 2011

May 2, 2000
February 18, 2011
February 2000
October 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005605 on ClinicalTrials.gov Archive Site
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Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer
Does Tamoxifen Prevent the Skeletal and Cardiovascular Morbidity of Chemotherapy in Premenopausal Women?

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:

  • 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with stage I or II breast cancer currently undergoing treatment with either chemotherapy or tamoxifen.

  • Breast Cancer
  • Osteoporosis
Not Provided
  • Tamoxifen group
  • Chemotherapy group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Female
35 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005605
NU 95B2, NU-95B2, NCI-G00-1737
Not Provided
Seema Khan, MD, Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Seema A. Khan, MD Robert H. Lurie Cancer Center
Northwestern University
February 2011

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