KEEPS Mammographic Density And Breast Health Ancillary Study

Summary

Combined estrogen and progestin therapy has been shown to increase mammographic density and incidence of breast cancer in randomized trials. The investigators propose to examine the effects of now commonly used low-dose combined hormone therapy (HT) regimens on breast density, rates of abnormal mammogram, and circulating estrogens in the ongoing, already-funded Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical trial with a primary goal of examining the effects of low-dose transdermal versus oral estrogen combined with cyclic micronized progesterone on progression of subclinical atherosclerosis in recently menopausal women. Prior studies of low-dose HT have been of short duration and small size. By determining the effects of low-dose hormone therapy on the breast, the proposed ancillary study will add important information about the estimated balance of risks and benefits associated with low-dose HT and will help guide future research trials.

Conditions

• Mammographic Density
• Abnormal Mammogram

Interventions

DRUG

CEE pill

Conjugated equine estrogens 0.45 mg/day

DRUG

Estradiol patch

Climara 50 mcg/day

DRUG

Active Progesterone

Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime

OTHER

Placebo tablet

Placebo tablet

OTHER

Placebo patch

placebo patch

OTHER

Placebo progesterone

placebo progesterone

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Kronos Longevity Research Institute

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Yale University

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Kathy Rexrode, MD · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

42 Years

Max Age

58 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-09-30

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• United States

Study Locations