KEEPS Mammographic Density And Breast Health Ancillary Study
KEEPS MDBHAS
2 other identifiers
interventional
517
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 13, 2015
CompletedFirst Posted
Study publicly available on registry
August 17, 2015
CompletedResults Posted
Study results publicly available
March 8, 2017
CompletedMarch 8, 2017
January 1, 2017
8.3 years
August 13, 2015
September 20, 2016
January 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
BIRADS Breast Density
Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.
Baseline (Prior to Randomization)
BIRADS Breast Density
Frequency of the BIRADS category 1 year after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.
Year 1
BIRADS Breast Density
Frequency of the BIRADS category 3-4 years after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.
Latest (Year 3 of 4)
Secondary Outcomes (1)
Abnormal Mammogram/Biopsy
baseline to 3 years
Study Arms (3)
CEE pill, active progesterone
ACTIVE COMPARATORConjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
estradiol patch, active progesterone
ACTIVE COMPARATORTransdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
placebo
PLACEBO COMPARATORPlacebo tablet, placebo patch, placebo progesterone
Interventions
Conjugated equine estrogens 0.45 mg/day
Climara 50 mcg/day
Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
Eligibility Criteria
You may qualify if:
- Women were 42-58 years of age, have had cessation of menses at or after age 40 and no menses for a minimum of 6 and a maximum of 36 months at screening.
- Subjects may or may not have had current vasomotor estrogen deficiency symptoms, had not taken estrogen- or progestogen-containing medication (oral contraceptive or hormone replacement) within 3 months of randomization, and had plasma FSH levels measured at ≥35 ng/ml and plasma E2 levels of \<40 pg/ml.
You may not qualify if:
- Subjects were excluded for increased endometrial thickness on ultrasound \>5 mm, unless endometrial biopsy was negative; for LDL ≥ 190 mg/dl or triglycerides ≥ 400 at screening, or use of lipid lowering drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- National Cancer Institute (NCI)collaborator
- Kronos Longevity Research Institutecollaborator
- Albert Einstein College of Medicinecollaborator
- Columbia Universitycollaborator
- Mayo Cliniccollaborator
- University of California, San Franciscocollaborator
- University of Utahcollaborator
- University of Washingtoncollaborator
- Yale Universitycollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Rulla Tamimi
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy Rexrode, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
August 13, 2015
First Posted
August 17, 2015
Study Start
September 1, 2005
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
March 8, 2017
Results First Posted
March 8, 2017
Record last verified: 2017-01