NCT07434128 · OHSU Knight Cancer Institute
Mammogram Pretreatment With Ulipristal Acetate
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Mammogram
Participants will undergo their standard of care mammogram.
OTHER
Survey Administration
Ancillary studies
DRUG
Ulipristal Acetate
Given orally
Primary outcome measures
Difference in percent dense area
Time frame: From baseline mammogram to study day 20 mammogram
DEEP-Libra will be utilized to obtain the change in breast percent density value per patient between the historical baseline mammogram and mammogram following ulipristal acetate. Both images (baseline and mammogram following ulipristal acetate) will be independently analyzed with DEEP-Libra to generate the percent dense area and then the mean difference will be recorded. The mean and standard deviation of the difference in percent dense area between the baseline and mammogram following ulipristal acetate will be reported.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 dense) for which images are available for analysis
- Report no history of breast cancer or symptoms concerning for breast cancer such as a self-palpated mass
- Reasonably assumed to be premenopausal by history of regular menses. For individuals who do not menstruate (due to hysterectomy or endometrial ablation), premenopausal status will be determined clinically by the absence of symptoms of menopause including weekly hot flashes which is consistent with clinical care
Exclusion criteria
- 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
- History of allergy to UPA
- A history of liver disease (including but not limited to viral or autoimmune hepatitis, non-alcoholic fatty liver disease, hemochromatosis or Wilson's disease), alcoholism or a history of liver function tests such as aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than 3 x the upper limit of normal without known etiology
- Seeking pregnancy during study duration or a positive urine pregnancy for people at risk of pregnancy who cannot be reasonably assumed not to be pregnant at the beginning of the intervention
- Use of CYP3A4 inducer or inhibitors which may alter plasma concentrations of study drug (See Appendix A for list of common drugs/herbs). Regarding recent use of CYP3A4 inducers or inhibitors, a washout period will be deemed sufficient if at least 14 days or 5 half lives of the drug have elapsed prior to initiation of the study drug, whichever is longer. Participants will be advised to abstain from CYP3A4 inducers or inhibitors during the study and will only be ineligible if unable to
- Contraindication to MRI including: pacemakers, wires, stents, defibrillator, implanted hear values, aneurysm clips, metal pin, join, or prosthesis, electric devices (stimulator or pump), mental fragments, hearing aids, middle/inner ear prosthesis or dentures
Where
- Portland, Oregon
Collaborators
Oregon Health and Science University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 3, 2026 · Source of record for eligibility and locations