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


N/A
35 Years
50 Years
Not Enrolling
Female
Breast Cancer, Osteoporosis

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Seema A. Khan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 95B2

NCT ID:

NCT00005605

Start Date:

February 2000

Completion Date:

October 2005

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • osteoporosis
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms
  • Osteoporosis

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611