ARV-471 for Breast Cancer

(VERITAC-2 Trial)

Not currently recruiting at 510 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ARV-471 for individuals with advanced metastatic breast cancer. The researchers aim to compare the effectiveness of ARV-471 to Fulvestrant, a standard treatment. Suitable candidates have breast cancer that cannot be treated with surgery or radiation, have specific types of breast cancer (ER+/HER2-), and have previously received certain cancer therapies. Participants must have measurable cancer and be willing to provide blood and tissue samples. As a Phase 3 trial, this is the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ARV-471, also known as vepdegestrant, is generally well-tolerated by patients with advanced breast cancer. In earlier studies, patients who took ARV-471 experienced few side effects, indicating its safety for most people. Another study found that ARV-471 was effective even for patients who had tried other treatments, highlighting its potential safety and effectiveness. For those considering joining the trial, current evidence suggests ARV-471 is generally safe with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

ARV-471 is unique because it targets breast cancer by degrading estrogen receptors, which is different from many current treatments that primarily block these receptors. This novel mechanism of action means ARV-471 could potentially be more effective at reducing tumor growth. Researchers are excited about this treatment because it offers a promising new approach for patients with hormone receptor-positive breast cancer, who may not respond well to existing therapies like tamoxifen or aromatase inhibitors.

What evidence suggests that this trial's treatments could be effective for advanced metastatic breast cancer?

Research has shown that ARV-471, which participants in this trial may receive, holds promise for treating advanced breast cancer that has spread. In one study, about 38 out of every 100 patients responded positively to ARV-471, experiencing some benefit from the treatment. Specifically, ARV-471 helped patients live nearly three months longer without their cancer worsening compared to those taking the standard treatment, fulvestrant, which is another option in this trial. ARV-471 also effectively reduced the activity of estrogen receptors, which often contribute to breast cancer growth. Overall, these findings suggest ARV-471 could be a valuable option for managing this type of cancer. ^{2 4 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ir.arvinas.com ir.arvinas.com/news-releases/news-release-details/arvinas-announces-arv-471-achieves-clinical-benefit-rate-38

Arvinas Announces ARV-471 Achieves a Clinical Benefit ... In the VERITAC trial, ARV-471 shows a favorable tolerability profile and demonstrates a clinical benefit rate of 38% (total n=71) (CBR: rate of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39072356/

VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ... The global, randomized Phase III VERITAC-2 study compares efficacy and safety of vepdegestrant versus fulvestrant in adults with ER+/HER2- advanced breast ...

3. arvinasmedical.com arvinasmedical.com/wp-content/uploads/2022/06/Teh-AACR-2023-2.pdf

Enhanced Efficacy of Vepdegestrant (ARV-471), a Novel ... ARV-471 demonstrates superior ER degradation and antitumor activity compared to fulvestrant in endocrine sensitive and resistant xenograft models (1,2) and has ...

4. pfizer.com pfizer.com/news/press-release/press-release-detail/arvinas-and-pfizers-vepdegestrant-significantly-improves

Arvinas and Pfizer's Vepdegestrant Significantly Improves ... Pivotal Phase 3 VERITAC-2 clinical trial results presented at ASCO demonstrate 2.9-month improvement in median progression-free survival ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05463952

A Study to Learn About the Vepdegestrant (ARV-471, PF- ... The purpose of this clinical trial is to learn about the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ARV-471 as monotherapy in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700046/

Safety and pharmacokinetics of vepdegestrant in Japanese ... Vepdegestrant 200 mg QD was well tolerated in Japanese patients with ER+/HER2- advanced breast cancer with no notable differences in pharmacokinetics from ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05463952

NCT05463952 | A Study to Learn About the Vepdegestrant ... The purpose of this clinical trial is to learn about the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ARV-471 as monotherapy in ...