Study on Vepdegestrant with Other Medicines for Advanced or Metastatic Breast Cancer (Sub-Study A)

Sponsor: Pfizer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05548127

Provider View

This clinical trial is exploring the safety and effects of a new medicine, Vepdegestrant (ARV-471), when used with another medicine, abemaciclib, for treating advanced or metastatic breast cancer that is sensitive to hormones but no longer responding to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to understand how safe and effective the study medicine, ARV-471, is when combined with abemaciclib for treating advanced or metastatic breast cancer. This type of breast cancer is sensitive to hormonal therapy and has spread to other parts of the body, making it difficult to treat with surgery or radiation. Participants will take ARV-471 once a day and abemaciclib twice a day, both by mouth at home. The study will monitor participants to see if the treatment is safe and effective, continuing until the cancer stops responding or side effects become too severe. Clinic visits will occur approximately every 4 weeks.

Description

This sub-study, part of the larger TACTIVE-U platform, focuses on evaluating ARV-471 in combination with other cancer treatments for patients with Estrogen Receptor Positive (ER+) Advanced or Metastatic Breast Cancer. ARV-471 serves as the main treatment, combined with other relevant cancer drugs for ER+ breast cancer. Participants will receive ARV-471 and abemaciclib, both taken orally at home. The study will assess the safety and effectiveness of this combination therapy, with participants continuing treatment until their cancer no longer responds or side effects become too severe. Regular clinic visits will help monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced or metastatic breast cancer that is estrogen receptor positive (ER+) and HER2 negative, which cannot be fully treated with surgery.
  • Previously received 1 to 2 lines of treatment for advanced/metastatic cancer, including a CDK4/6 inhibitor.
  • Have at least one measurable tumor.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have a severe health crisis that could lead to life-threatening complications soon.
  • Have a history of lung problems caused by medication or significant lung function issues.
  • Have newly diagnosed or symptomatic brain metastases or other serious brain conditions unless they have been treated and stable for at least 14 days.
  • Have had another type of cancer in the past 3 years, except for certain skin or cervical cancers that have been treated.
  • Have inflammatory breast cancer.
  • Have significant heart problems or diseases.
  • Are taking medications or supplements that strongly affect liver enzymes or heart rhythm.
  • Have kidney, liver, or bone marrow function issues.
  • Have an active infection.

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