ARV-471 for Breast Cancer

(VERITAC-2 Trial)

Recruiting in Palo Alto (17 mi)

+439 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a new oral medicine, ARV-471, against an existing injectable treatment, fulvestrant, in people with advanced breast cancer that has spread. Both medicines aim to slow cancer growth by targeting estrogen receptors. ARV-471 is developed as an oral alternative to fulvestrant.

Eligibility Criteria

This trial is for adults with advanced metastatic breast cancer that can't be removed by surgery or treated with radiation. They should have a certain type of cancer (ER+/HER2-) and must have had specific prior treatments, including CDK4/6 inhibitors. People with severe illnesses, poor organ function, high-risk visceral disease, previous ARV-471 treatment or similar drugs are not eligible.

Inclusion Criteria

My breast cancer is ER positive and HER2 negative.

I've had specific treatments for my cancer that has spread, including a CDK4/6 inhibitor.

I am fully active or can carry out light work.

Exclusion Criteria

My liver, kidneys, and bone marrow are not working well.

I haven't taken specific cancer treatments like ARV-471, fulvestrant, or chemotherapy for advanced disease.

Participants with significant concomitant illness

Participant Groups

The study tests a new drug called ARV-471 against Fulvestrant in treating advanced breast cancer. Participants will receive one of these treatments to see how well they work and compare their effects on the disease.

Group I: ARV-471 Experimental Treatment 1 Intervention

Group II: Fulvestrant Active Control 1 Intervention

ARV-471 is already approved in United States for the following indications:

🇺🇸 Approved in United States as Vepdegestrant for:

• None approved; under investigation for ER+/HER2- metastatic breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MSK Basking Ridge Basking Ridge, NJ

MSK Monmouth Middletown, NJ

Tennessee Oncology, PLLC Dickson, TN

Florida Cancer Specialists Largo, FL

More Trial Locations

Who Is Running the Clinical Trial?

Pfizer Lead Sponsor

Arvinas Estrogen Receptor, Inc. Industry Sponsor

References