Vepdegestrant + PF-07220060 for Breast Cancer

Not currently recruiting at 67 trial locations
PC
Overseen ByPfizer CT.gov Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether two oral medications, vepdegestrant and PF-07220060 (also known as atirmociclib), are safe and effective for treating advanced metastatic breast cancer, a challenging cancer that has spread beyond the breast. The trial seeks participants whose cancer is estrogen receptor positive (sensitive to hormone therapy) and who have stopped responding to previous treatments. Participants will take both medications at home and visit the study clinic approximately every four weeks. The trial continues until the cancer no longer responds or side effects become too severe.

As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer research.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications, foods, or supplements that strongly affect specific liver enzymes (CYP3A or UGT2B7) or that can cause heart rhythm issues. It's best to discuss your current medications with the trial team to see if any need to be stopped.

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

Research has shown that vepdegestrant, when used alone, is generally well tolerated by patients with certain types of breast cancer, with most experiencing only mild side effects. It has also proven effective in patients whose breast cancer is difficult to treat.

Regarding PF-07220060, limited information exists about its safety when combined with vepdegestrant. As this trial is in its early stages, researchers are determining the best dose and monitoring for side effects. The treatment has not yet been proven safe in large groups. Notably, both medications are taken orally, which can be more comfortable than injections.

In summary, while some evidence supports the safety of vepdegestrant, the combination with PF-07220060 is still under study for safety and effectiveness. Trial participants will help gather more information about how well people tolerate this treatment combination.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Vepdegestrant combined with PF-07220060 because this duo represents a novel approach to treating breast cancer. Unlike standard treatments like hormone therapies or chemotherapy, this combination targets cancer cells in a unique way. Vepdegestrant is an oral selective estrogen receptor degrader, which helps break down estrogen receptors that fuel certain breast cancers. Meanwhile, PF-07220060 is designed to inhibit specific proteins that promote cancer cell growth. Together, these treatments offer a promising new strategy for attacking breast cancer on multiple fronts.

What evidence suggests that vepdegestrant and PF-07220060 could be effective for advanced metastatic breast cancer?

Research shows that vepdegestrant breaks down proteins that help breast cancer cells grow, making it especially promising for tumors that require estrogen. Early studies have shown that PF-07220060 can combat tumors in individuals with advanced solid tumors. In this trial, participants will receive a combination of vepdegestrant and PF-07220060, which might effectively treat advanced metastatic breast cancer, particularly in hormone-sensitive cases that no longer respond to current treatments. Although more research is needed, these early findings offer hope for this challenging condition.12356

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people with advanced or metastatic breast cancer that's estrogen receptor positive and not responding to prior treatments. Participants should have at least one measurable lesion, be in good physical condition (ECOG PS ≤2), and must have had specific previous therapies including a CDK4/6 inhibitor regimen.

Inclusion Criteria

I have a cancer lesion that can (or cannot) be measured by standard criteria.
I have had one chemotherapy treatment for advanced/metastatic breast cancer, but no antibody-drug treatments.
I can care for myself and perform daily activities with little to no assistance.
See 8 more

Exclusion Criteria

I have kidney, liver, or bone marrow problems.
I have heart problems or significant heart disease.
I currently have an active infection.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vepdegestrant and PF-07220060 orally in 28-day cycles until cancer progression or severe side effects

Up to approximately 1 year
Visits at the study clinic about every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PF-07220060
  • Vepdegestrant
Trial Overview The study tests the combination of two oral medications, vepdegestrant and PF-07220060, as a potential treatment for tough-to-treat breast cancer that has spread. The effectiveness and safety of these drugs are being evaluated while participants take them at home until their cancer worsens or side effects become severe.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: vepdegestrant in combination with PF-07220060Experimental Treatment2 Interventions

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Arvinas Estrogen Receptor, Inc.

Industry Sponsor

Trials
19
Recruited
2,400+

Published Research Related to This Trial

Palbociclib, in combination with letrozole, is FDA-approved for treating postmenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer, showing its efficacy as an initial therapy.
The combination of palbociclib with fulvestrant has been found to provide better outcomes than fulvestrant alone for patients who have previously progressed on endocrine therapy, highlighting its potential in advanced treatment scenarios.
Palbociclib: a first-in-class CDK4/CDK6 inhibitor for the treatment of hormone-receptor positive advanced breast cancer.Lu, J.[2022]
In a real-world study of 191 women with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer, the combination of palbociclib and endocrine therapy showed a clinical benefit rate of 59.8%, with a median progression-free survival (PFS) of 13 months.
The treatment was more effective when given as a first-line therapy, resulting in a median PFS of 14 months, compared to shorter PFS durations in later treatment lines, indicating that earlier intervention may enhance treatment outcomes.
Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study.Palumbo, R., Torrisi, R., Sottotetti, F., et al.[2022]
In a presurgical study involving 46 women with ER+ HER2- breast cancer, AZD9496, an oral selective estrogen receptor degrader (SERD), demonstrated biological activity by reducing estrogen receptor (ER) levels, but was not superior to fulvestrant, the standard injectable SERD, in efficacy.
Both AZD9496 and fulvestrant effectively reduced progesterone receptor (PR) and Ki-67 levels, indicating their impact on tumor biology, but no new safety concerns were identified, suggesting that AZD9496 is safe to use.
A Randomized, Open-label, Presurgical, Window-of-Opportunity Study Comparing the Pharmacodynamic Effects of the Novel Oral SERD AZD9496 with Fulvestrant in Patients with Newly Diagnosed ER+ HER2- Primary Breast Cancer.Robertson, JFR., Evans, A., Henschen, S., et al.[2021]

Citations

Vepdegestrant (ARV-471)Vepdegestrant is an investigational compound. Its safety and efficacy have not been established. * Vepdegestrant is being co-developed with Arvinas.
TACTIVE-K: Phase 1b/2 study of vepdegestrant, a ...A first-in-human phase 1/2a study (NCT04557449) demonstrated promising antitumor activity with PF-07220060 in pts with advanced solid tumors ...
NCT06206837 | A Study to Learn About Vepdegestrant ...The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can ...
VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ER ...The global, randomized Phase III VERITAC-2 study compares efficacy and safety of vepdegestrant versus fulvestrant in adults with ER+/HER2- advanced breast ...
Arvinas Updates Guidance for First- and Second-Line ...Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen ...
Arvinas and Pfizer's Vepdegestrant (ARV-471) Receives ...Arvinas and Pfizer's Vepdegestrant (ARV-471) Receives FDA Fast Track Designation for the Treatment of Patients with ER+/HER2- Metastatic Breast ...
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