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Mammography ScreeningPhase 2NCT07434128

Mammogram Pretreatment With Ulipristal Acetate

A Phase 2 study testing Biospecimen Collection, Magnetic Resonance Imaging and Mammogram in people with Mammography Screening and Breast Density, run by OHSU Knight Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Mammography Screening, Breast Density
What is being tested?
Biospecimen Collection, Magnetic Resonance Imaging and Mammogram
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
21 Aug 2026to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Abigail Liberty, 503-494-3666, liberty@ohsu.edu

    Abigail Liberty

    Recruiting

Other trials in United States

About this study

Official title: Progesterone Receptor Modulator Mammogram Pretreatment for Premenopausal People With a History of Dense Breast Tissue

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate change in percent dense area from antecedent to study screening mammograms.

SECONDARY OBJECTIVES:

  1. 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:

  1. 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).

III. To describe the effect of the intervention on routine clinical care. IV. To determine the longitudinal effect of the intervention on primary objective (clinical breast density score).

OUTLINE:

Patients receive ulipristal acetate orally (PO) every 5 days for 4 doses in the absence of unacceptable toxicity (study days 1, 5, 10 and 15). Patients then undergo a mammogram on study day 20. Patients also undergo base magnetic resonance imaging (MRI) and blood sampling which will be repeated on study day 20.

After completion of study intervention, patients are followed up at 1-7 days and may be followed up to 24 months for results of subsequent screening mammograms.

Being tested
Biospecimen Collection, Magnetic Resonance Imaging, Mammogram, Survey Administration, Ulipristal Acetate
Keywords
Progesterone receptor modulators

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • MammogramProcedure or surgery

    Participants will undergo their standard of care mammogram.

  • Survey AdministrationOther

    Ancillary studies

  • Ulipristal AcetateDrug

    Also called CDB-2914, Ella, Esmya, PGL-4001

    Given orally

Study groups in NCT07434128
Study groupRoleWhat they receive
Diagnostic (ulipristal acetate)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Procedure: Mammogram; Other: Survey Administration; Drug: Ulipristal Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline mammogram to study day 20 mammogram

Secondary outcomes (7)

  1. Progesterone level

    Each participant will be categorized as being in their luteal phase, follicular phase, or as experiencing imminent ovulation at the time of both breast magnetic resonance imagings (MRI): at baseline and immediately after completion of the study drug. The frequency and proportion of participants in each category will be reported and assessed descriptively, as well as median and range, or mean and standard deviation.

    Measured: At time of baseline MRI and at study day 20

  2. Estradiol level

    Each participant will be categorized as being in their luteal phase, follicular phase, or as experiencing imminent ovulation at the time of both breast MRIs: at baseline and immediately after completion of the study drug. The frequency and proportion of participants in each category will be reported and assessed descriptively, as well as median and range, or mean and standard deviation.

    Measured: At time of baseline MRI and at study day 20

  3. Luteinizing hormone level

    Each participant will be categorized as being in their luteal phase, follicular phase, or as experiencing imminent ovulation at the time of both breast MRIs: at baseline and immediately after completion of the study drug. The frequency and proportion of participants in each category will be reported and assessed descriptively, as well as median and range, or mean and standard deviation.

    Measured: At time of baseline MRI and at study day 20

  4. Patient reported doses and deviations greater than 24 hours from recommended doses

    Administration of the study drug and deviations of the study drug administration greater than 24 hours will be described and utilized for determination of study population from the first dose of the study drug to the day of the mammogram following ulipristal acetate.

    Measured: Study days 1, 5, 10 and 15.

  5. Serum ulipristal acetate drug levels

    Will be collected on the day of the mammogram following ulipristal acetate and presented descriptively (mean, standard deviation) and only confirm receipt of final dose of study drug.

    Measured: Study day 20

  6. Incidence of adverse events

    Responses from these symptom surveys from first dose of study drug to the day of mammogram completed following ulipristal acetate will be aggregated and a binary variable will be generated to determine whether participants ever, or never, during the study period, reported each side effect/serious adverse events assessed in the surveys.

    Measured: Study days 5, 10, 15 and 20

  7. Acceptability of intervention

    The frequency and proportion of participants rating the intervention as tolerable/acceptable will be reported and assessed descriptively.

    Measured: Up to 7 days after study day 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start21 Aug 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07434128
Sponsor's protocol ID
STUDY00028348
Other IDs
NCI-2026-00503, STUDY00028348
Status last verified
Sep 2026
First submitted
11 Feb 2026
Last updated
3 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Magnetic Resonance Imaging and Mammogram in people with Mammography Screening and Breast Density, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in percent dense area (time frame: From baseline mammogram to study day 20 mammogram). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07434128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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