Mipping density before a mammogram with Ulipristal Acetate
Official title: Progesterone Receptor Modulator Mammogram Pretreatment for Premenopausal People With a History of Dense Breast Tissue
Run by OHSU Knight Cancer Institute · NCT07434128 · Data updated 2026-11-12
This phase 2 study tests whether taking ulipristal acetate before a screening mammogram helps reduce breast density in people with dense breasts to improve imaging.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 26 (estimated) |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | August 21, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07434128 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are premenopausal individuals aged 18-50 with a history of dense breast tissue (BI-RADS C or D) who are undergoing a screening mammogram and have no breast cancer history.
✕Probably not a fit
Patients with non-dense breasts, postmenopausal status, or known breast cancer would be unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase II interventional trial evaluating a short course of ulipristal acetate taken prior to a screening mammogram. Participants are premenopausal individuals aged 18-50 with dense breast tissue (BI-RADS C or D) and no history of breast cancer. The protocol involves four oral doses of ulipristal acetate every five days, followed by mammography and baseline MRI with blood sampling on day 20, plus follow-up to track outcomes and tolerability. Primary outcomes measure change in percent dense tissue on subsequent mammograms; secondary and exploratory aims include cycle phase after treatment, adherence, tolerability, radiographic density changes, background parenchymal enhancement on MRI, and impact on clinical care. The study includes biospecimen collection, MRI, mammography, and surveys, with follow-up up to 24 months for subsequent screening results.
Why it matters
Potential benefit: If successful, the approach could enable clearer mammograms for people with dense breasts, potentially aiding earlier detection of abnormalities.
How similar studies have gone: Prior research in similar approaches has explored hormonal modulation to impact imaging density, but this specific pre-mammogram ulipristal strategy is novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
OHSU Knight Cancer Institute
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Abigail Liberty — OHSU Knight Cancer Institute
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Intraoperative Methadone for Postoperative Pain in Head and Neck Cancer Patients
This trial tests whether giving methadone during surgery, in addition to standard fentanyl, helps control pain after head and neck cancer surgery more effectively than fentanyl alone.
-
Low-Dose Sirolimus for RUNX1-Related Platelet Disorder
This study tests whether a low daily dose of sirolimus is safe and feasible for adults with RUNX1 familial platelet disorder who may be at risk for cancer progression.
-
ctDNA-based monitoring in muscle-invasive bladder cancer
This study tests whether a blood-based ctDNA test can flag residual or returning disease in adults with muscle-invasive bladder cancer undergoing standard treatments.
-
A tailored web program to boost exercise and healthy eating for pancreatic cancer patients before surgery
This trial tests a personalized web portal called COMPASS to help adults with stage I–III pancreatic cancer who are receiving neoadjuvant chemotherapy to improve exercise and dietary habits.
-
Ruxolitinib with azacitidine maintenance after reduced-intensity stem cell transplant for AML
This study tests different doses of ruxolitinib first alone, then with azacitidine maintenance, in adults with acute myeloid leukemia undergoing reduced-intensity allogeneic stem cell transplantation to see if it is safe and tolerable and may help prevent relapse.
-
GET FIT Together: a socially enhanced exercise program for older men with prostate cancer
This program tests whether adding structured social support to supervised online exercise reduces cancer-related loneliness and improves mental and physical health in men 65 and older who have had prostate cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.