Ulipristal Acetate for Breast Density

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Hormonal medications, CYP3A4 drugs

Disqualifiers: Breast implants, Pregnancy, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Abigail Liberty

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

I have signed a consent form to join the study.

I am between 18 and 50 years old.

I was assigned female at birth and still have at least one ovary.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ulipristal acetate orally every 5 days for 4 doses, followed by a mammogram on study day 20

3 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits up to 24 months for subsequent screening mammograms

24 months

1-7 days after study day 20, then up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Ulipristal Acetate

How Is the Trial Designed?

Group I: Diagnostic (uliprostal acetate) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+