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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1b: Number of Participants With Dose Limiting Toxicities

Phase 2: Percentage of Participants With Objective Response by investigator assessment

Secondary study objectives

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)

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