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vepdegestrant in combination with 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

Study 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.

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,941 Total Patients Enrolled

111 Trials studying Breast Cancer

36,379 Patients Enrolled for Breast Cancer

Arvinas Estrogen Receptor, Inc.Industry Sponsor

17 Previous Clinical Trials

2,304 Total Patients Enrolled

7 Trials studying Breast Cancer

1,590 Patients Enrolled for Breast Cancer

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,156 Total Patients Enrolled

42 Trials studying Breast Cancer

12,743 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this investigation presently open?

"As per clinicaltrials.gov, the current status of this trial indicates that patient recruitment is no longer ongoing. The trial was first listed on 2/29/2024 and last updated on 2/6/2024. However, amidst the numerous active studies seeking participants at present, this particular trial has concluded its search for candidates."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The primary objective of this observation, spanning approximately 28 days, is to assess the Phase 2: Proportion of Participants Displaying Tangible Response by evaluator evaluation. Additional endpoints include examining Phase 1b and Phase 2: Duration of Response as reviewed by evaluators. This entails measuring the time from initial confirmation of response until tumor progression is noted or mortality occurs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.

2024. "A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06206837.

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