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Progesterone Receptor Modulator Mammogram Pretreatment for Premenopausal People With a History of Extremely Dense Breast Tissue
This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of extremely dense breast tissue. One limitation to breast cancer screening with mammography is dense breast tissue, which decreases the sensitivity of screening as breast density masks cancer and precancerous lesions. Ulipristal acetate lowers the amount of progesterone made by the body which may temporarily decrease the density of the breast tissue, allowing for a more accurate mammogram for people with extremely dense breast tissue.
PRIMARY OBJECTIVE: I. To evaluate change in percent dense area from antecedent to study screening mammograms. SECONDARY OBJECTIVES: I. To assess for menstrual cycle phase following this regimen of ulipristal acetate (UPA). II. To assess adherence, tolerability and acceptability of the short course of UPA prior to a mammogram. EXPLORATORY OBJECTIVES: I. To determine the presence of radiographic changes in clinical breast density on screening mammograms following a course of UPA. II. To characterize a change in background parenchymal enhancement (BPE) on breast magnetic resonance (MR). III. To describe the effect of the intervention on routine clinical care. IV. To determine the longitudinal effect of the intervention on primary objective (clinical breast density score). OUTLINE: Patients receive ulipristal acetate orally (PO) every 5 days for 4 doses in the absence of unacceptable toxicity (study days 1, 5, 10 and 15). Patients then undergo a mammogram on study day 20. Patients also undergo base magnetic resonance imaging (MRI) and blood sampling which will be repeated on study day 20. After completion of study intervention, patients are followed up at 1-7 days and may be followed up to 24 months for results of subsequent screening mammograms.
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
No
OHSU Knight Cancer Institute
Portland, Oregon, United States
Start Date
April 2, 2026
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2027
Last Updated
February 25, 2026
26
ESTIMATED participants
Biospecimen Collection
PROCEDURE
Magnetic Resonance Imaging
PROCEDURE
Mammogram
PROCEDURE
Survey Administration
OTHER
Ulipristal Acetate
DRUG
Lead Sponsor
OHSU Knight Cancer Institute
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05181059