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Vepdegestrant + PF-07220060 for Breast Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS = 0 or 1 (Phase1b); ≤2 (Phase2)
1 prior CDK4/6 inhibitor-based regimen required
Must not have
Impaired cardiovascular function or clinically significant cardiovascular diseases
Known active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights

Summary

This trial is testing a new potential treatment for advanced metastatic breast cancer. Participants will receive two medications by mouth and will be monitored to see how safe and effective the treatment is. They will continue taking

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the exact side effects aren't listed here, common ones may include nausea, fatigue, pain at different sites depending on where the cancer has spread, hormonal changes due to therapy sensitivity, and possible reactions to new medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself and perform daily activities with little to no assistance.
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I have been treated with a CDK4/6 inhibitor before.
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My breast cancer cannot be removed with surgery to cure it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have heart problems or significant heart disease.
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I currently have an active infection.
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My condition is critical, with life-threatening complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Number of Participants With Dose Limiting Toxicities
Phase 2: Percentage of Participants With Objective Response by investigator assessment
Secondary outcome measures
Phase 1b and Phase 2: Duration of Response by investigator assessment.
Phase 1b and Phase 2: Evaluation of Safety of Vepdegestrant in combination with PF-07220060 (number of participants experiencing any AE, SAE, treatment-related AE and treatment-related SAE)
Phase 1b and Phase 2: Evaluation of Safety of Vepdegestrant in combination with PF-07220060 (number of participants with changes from baseline for ECG parameters)
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: vepdegestrant in combination with PF-07220060Experimental Treatment2 Interventions
vepdegestrant administered orally once daily (QD) continuously and PF-07220060 administered orally twice daily (BID) continuously on 28-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vepdegestrant
2024
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,705 Total Patients Enrolled
113 Trials studying Breast Cancer
36,130 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Industry Sponsor
17 Previous Clinical Trials
2,305 Total Patients Enrolled
7 Trials studying Breast Cancer
1,592 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,314 Total Patients Enrolled
44 Trials studying Breast Cancer
12,462 Patients Enrolled for Breast Cancer
~43 spots leftby Aug 2025
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