Mammogram Pretreatment With Ulipristal Acetate

NCT07434128 | Not Yet Recruiting Phase 2 FDA Drug

• 3 other identifiers: STUDY00028348NCI-2026-00503P30CA069533
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mammography Screening; Breast Density

Keywords

Progesterone receptor modulators

Outcome Measures

Primary Outcomes (1)

• Difference in percent dense area

  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.

  From baseline mammogram to study day 20 mammogram

Secondary Outcomes (7)

• Progesterone level

  At time of baseline MRI and at study day 20

• Estradiol level

  At time of baseline MRI and at study day 20

• Luteinizing hormone level

  At time of baseline MRI and at study day 20

• Patient reported doses and deviations greater than 24 hours from recommended doses

  Study days 1, 5, 10 and 15.

• Serum ulipristal acetate drug levels

  Study day 20

Study Arms (1)

Diagnostic (uliprostal acetate)

EXPERIMENTAL

Patients receive ulipristal acetate PO every 5 days for 4 doses in the absence of unacceptable toxicity. Patients then undergo a mammogram. Patients also undergo MRI and blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Procedure: Mammogram; Other: Survey Administration; Drug: Ulipristal Acetate

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Diagnostic (uliprostal acetate)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Diagnostic (uliprostal acetate)

Mammogram PROCEDURE

Participants will undergo their standard of care mammogram.

Diagnostic (uliprostal acetate)

Survey Administration OTHER

Ancillary studies

Diagnostic (uliprostal acetate)

Ulipristal Acetate DRUG

Given orally

Also known as: CDB-2914, Ella, Esmya, PGL-4001, RTI-3021-012, VA-2914

Diagnostic (uliprostal acetate)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Has an antecedent mammogram within 24 months with a Breast Imaging Reporting and Data System (BI-RADS) breast composition score of Category 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

You may not qualify if:

• Having a mammogram as part of a diagnostic process
• Current breast implants in one or both breasts
• 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
• Attempting pregnancy during the 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy; ulipristal acetate; ulipristal

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Abigail Liberty

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 25, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)