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A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women


Phase 1
20 Years
45 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women


OBJECTIVES:

Primary

- Determine whether breast density, as measured by digital mammography, decreases in
premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk
reduction.

- Determine whether breast density, as determined by a trained mammographer, decreases in
patients treated with this drug.

- Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary
steroids in patients treated with this drug.

Secondary

- Determine the effect of this drug on salivary steroids in regularly cycling and
amenorrheic patients.

- Correlate changes in breast density with tamoxifen-induced alterations in sex steroid
levels, as measured in the saliva, of patients treated with this drug.

OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the
absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast
cancer (patients undergoing risk reduction).

Patients undergo mammography to determine breast density at baseline, at 6 and 12 months,
and then annually for 4 years. Patients also collect daily salivary samples during the
30-day periods surrounding the imaging studies to measure salivary estradiol and
progesterone levels. The results of the salivary hormone studies are correlated with density
changes at study completion.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast
cancer risk reduction

- Undergoing mammography at least annually

- No bilateral breast cancer or stage IV breast cancer

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 20 to 45

Sex

- Female

Menopausal status

- Premenopausal

- No change in menstrual patterns within the past 6 months

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- No planned pregnancy within the next 5 years

- No medical or psychiatric disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for breast cancer

Endocrine therapy

- See Disease Characteristics

- No prior tamoxifen for more than 1 month in duration

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:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NCI 00B2

NCT ID:

NCT00086749

Start Date:

February 2003

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location

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