Study on Vepdegestrant and PF-07220060 for Advanced or Metastatic Breast Cancer

Sponsor: Pfizer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06206837

Provider View

This clinical trial is exploring the safety and effects of combining two oral medications, vepdegestrant and PF-07220060, for treating advanced breast cancer that has spread to other parts of the body and is difficult to treat. The study focuses on patients whose cancer is sensitive to hormonal therapy but has stopped responding to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to evaluate if the combination of vepdegestrant and PF-07220060 can be a safe and effective treatment for advanced breast cancer that has spread beyond the breast. Participants will take both medications at home and visit the study clinic approximately every four weeks. The treatment will continue until the cancer stops responding or side effects become too severe.

Description

This study is a Phase 1b/2 trial that looks at the safety and effectiveness of vepdegestrant combined with PF-07220060 in patients with advanced or metastatic breast cancer that is estrogen receptor positive and HER2 negative. All participants will take the medications by mouth at home. The study will monitor how well the treatment works and any side effects experienced by the participants. The trial will continue until the cancer no longer responds to the treatment or side effects become too severe.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with breast cancer that cannot be surgically removed with the intent to cure.
  • Cancer must be estrogen receptor positive (ER+) and HER2 negative (HER2-).
  • For Phase 1b: Must have had at least one prior standard treatment for advanced/metastatic breast cancer, with no more than one prior chemotherapy regimen.
  • For Phase 2: Must have had one or two prior hormone therapy treatments for advanced/metastatic breast cancer, with the most recent lasting more than six months.
  • Must have previously received a CDK4/6 inhibitor-based treatment.
  • Must have either non-measurable lesions (Phase 1b) or at least one measurable lesion (Phase 2).
  • Must have an ECOG performance status of 0 or 1 (Phase 1b) or 0 to 2 (Phase 2).

Exclusion Criteria

  • Immediate risk of life-threatening complications due to cancer.
  • Conditions that prevent proper absorption of the study medications.
  • Newly diagnosed or symptomatic brain metastases or other central nervous system issues unless treated and stable for at least 28 days.
  • History of other cancers within the past three years, except for certain skin cancers or cervical cancer treated successfully.
  • Inflammatory breast cancer is excluded.
  • Significant heart problems or diseases affecting heart function.
  • Use of certain medications, foods, or supplements that affect how the study drugs work.
  • Poor kidney, liver, or bone marrow function.
  • Active infections.

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