We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00005605
First Posted: January 27, 2003
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Northwestern University
  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?

Resource links provided by NLM:


Further study details as provided by Northwestern University:

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stage I or II breast cancer currently undergoing treatment with either chemotherapy or tamoxifen.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005605


Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
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
First Submitted: May 2, 2000
First Posted: January 27, 2003
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by Northwestern University:
osteoporosis
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents