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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 is ongoing, but not recruiting participants.

Sponsors and Collaborators: Robert H. Lurie Cancer Center
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
Cancer-Related Problem/Condition
Drug: tamoxifen citrate

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Heart Disease in Women    Heart Diseases   

Drug Information available for:   Tamoxifen    Tamoxifen citrate    Citric acid    Sodium Citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
Official Title:   Does Tamoxifen Prevent the Skeletal and Cardiovascular Morbidity of Chemotherapy in Premenopausal Women?

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   February 2000

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.

  Eligibility
Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005605

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University    
      Chicago, Illinois, United States, 60611

Sponsors and Collaborators
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Seema A. Khan, MD     Robert H. Lurie Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067728, NU-95B2, NCI-G00-1737
First Received:   May 2, 2000
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00005605
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
osteoporosis  
stage I breast cancer  
stage II breast cancer  

Study placed in the following topic categories:
Heart Diseases
Skin Diseases
Citric Acid
Osteoporosis
Breast Neoplasms
Tamoxifen
Breast Diseases

Additional relevant MeSH terms:
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2008




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