ARV-471 for Breast Cancer

(VERITAC-2 Trial)

Recruiting at 439 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must be taking: CDK4/6 inhibitors

Must not be taking: Fulvestrant, Elacestrant, mTOR inhibitors, others

Disqualifiers: Visceral spread, Brain metastases, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: Until disease progression or unacceptable toxicity

624 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have taken certain treatments like ARV-471, fulvestrant, and others. It's best to discuss your current medications with the trial team to see if they are allowed.

What data supports the effectiveness of the drug ARV-471 for breast cancer?

Research on similar treatments shows that targeting the androgen receptor (AR) in breast cancer can be effective. For example, ARD-61, a drug that degrades AR, has been shown to effectively inhibit tumor growth in AR-positive breast cancer models, suggesting that AR-targeting drugs like ARV-471 may also be effective. ^{1 2 3 4 5}

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ARV-471 or Fulvestrant. ARV-471 is taken orally daily, while Fulvestrant is administered via intramuscular injections on Day 1 and again 2 weeks later, then every 28 days.

Until disease progression or unacceptable toxicity

Visits approximately every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 years

Every 8 weeks during the first 48 weeks, then every 12 weeks

Treatment Details

Interventions

• ARV-471
• Fulvestrant

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Arvinas Estrogen Receptor, Inc.

Industry Sponsor

Trials

19

Recruited

2,400+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A novel inhibitor of ARfl and ARv7 induces protein degradation to overcome enzalutamide resistance in advanced prostate cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A highly potent PROTAC androgen receptor (AR) degrader ARD-61 effectively inhibits AR-positive breast cancer cell growth in vitro and tumor growth in vivo. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Androgen Receptor Expression and Bicalutamide Antagonize Androgen Receptor Inhibit β-Catenin Transcription Complex in Estrogen Receptor-Negative Breast Cancer. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Androgen Receptor in Breast Cancer: From Bench to Bedside. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Small-Molecule-Mediated Degradation of the Androgen Receptor through Hydrophobic Tagging. [2021]