Progesterone Receptor Modulator Mammogram Pretreatment for Premenopausal People With a History of Dense Breast Tissue
OHSU Knight Cancer Institute
Summary
This phase II trial tests whether taking ulipristal acetate prior to a mammogram decreases breast density for people with a history of 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 dense breast tissue.
Description
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). I…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participant must provide written informed consent before any study-specific procedures or interventions are performed * Ages 18-50 years. The maximum age cut off is due to the intervention only applying to premenopausal physiology only * Assigned female at birth with at least one ovary in situ. Members of all races and ethnic groups will be included * Presenting for a screening mammogram * Has an antecedent mammogram within 24 months with a Breast Imaging Reporting and Data System (BI-RADS) breast composition score of Category C (heterogeneously dense) or D (extremely de…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureMammogram
Participants will undergo their standard of care mammogram.
- OtherSurvey Administration
Ancillary studies
- DrugUlipristal Acetate
Given orally
Location
- OHSU Knight Cancer InstitutePortland, Oregon