Vepdegestrant + PF-07220060 for Breast Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vepdegestrant and PF-07220060 orally in 28-day cycles until cancer progression or severe side effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PF-07220060
- Vepdegestrant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
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