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A Prospective, Randomized, Placebo-Controlled Trial of the Effects of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women


N/A
30 Years
50 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

A Prospective, Randomized, Placebo-Controlled Trial of the Effects of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women


OBJECTIVES:

Primary

- Determine the effect of 4-hydroxytamoxifen gel on breast density, as measured by
digital mammography, in premenopausal women.

- Determine the effect of this gel on breast density in these participants, as defined by
the BIRADS lexicon.

Secondary

- Determine the effect of this gel on salivary sex steroid levels in these participants.

- Determine the effect of this gel on quality of life of these participants.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are
randomized to 1 of 2 treatment arms.

- Arm I: Participants apply 4-hydroxytamoxifen gel in 4 metered doses daily to each
breast beginning on the first day after cessation of the first menstrual period after
digital mammography is performed.

- Arm II: Participants apply placebo gel as in arm I. In both arms, treatment continues
for 1 year.

In both arms, participants collect daily saliva samples for 4 menstrual cycles during the
study. Three of the saliva collections occur during the cycles encompassing the time periods
when imaging studies are performed (months 0, 6, and 12). The fourth collection takes place
during the first month that gel is applied to the breast.

Participants also undergo digital mammography at baseline, 6 months, and 1 year.

Participants who develop clinical breast problems considered suspicious for cancer
discontinue study treatment until a histological diagnosis is established. Those found to
have breast cancer are removed from the study and those with benign disease continue the
study. If an excisional biopsy is performed, density measurements are made on the opposite
breast.

Quality of life is assessed at baseline, 1 month, 6 months, and 1 year.

PROJECTED ACCRUAL: A total of 100 participants (50 per treatment arm) will be accrued for
this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Premenopausal as determined by a menstrual history of no change in menstrual pattern
within the past 6 months

- Undergoing mammography at least annually

- No prior breast cancer

- No clinical breast abnormalities suspicious for cancer

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 30 to 50

Sex

- Female

Menopausal status

- See Disease Characteristics

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- Fertile patients must use effective barrier contraception

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- More than 3 months since prior oral contraceptives or other estrogen- or
progesterone-containing drugs

- No prior tamoxifen for more than 1 month duration

- No concurrent oral contraceptives or other estrogen- or progesterone-containing drugs

- No other concurrent antiestrogen medications

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Screening

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 00B3

NCT ID:

NCT00084344

Start Date:

April 2003

Completion Date:

July 2004

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

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