About this trial
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.
Eligibility criteria
Qualifiers
Participant or legally authorized representative (LAR) 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
Disqualifiers
Having a mammogram as part of a diagnostic process
Current breast implants in one or both breasts
Pregnant, less than 1 year postpartum or breastfeeding within last 6 months at the time of their antecedent mammogram or their current mammogram. This exclusion is due to known changes in mammograms during pregnancy and postpartum that would preclude comparative analyses
Using hormonal medications including estrogens or progestins
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Magnetic Resonance Imaging
- Mammogram
- Survey Administration
- Ulipristal Acetate
Treatment groups
Sponsors and collaborators
OHSU Knight Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator