Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00086749

Enrollment

Registered

2004-07-12

Start date

2003-02-28

Completion date

2007-12-31

Last updated

2012-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Brief summary

RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by decreasing estrogen levels. PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Countries

United States

Outcome results