TACTIVE-U: Study on Vepdegestrant with Other Medicines for Advanced or Metastatic Breast Cancer (Sub-Study B)

Sponsor: Pfizer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05573555

Provider View

This clinical trial is exploring the safety and effects of a new medicine, ARV-471, when taken with another medicine, ribociclib, for treating advanced or metastatic breast cancer that is sensitive to hormonal therapy 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 used with ribociclib for treating advanced or metastatic breast cancer. This type of cancer has spread to other parts of the body and cannot be fully treated with surgery or radiation. The study focuses on breast cancer that is sensitive to hormonal therapy (estrogen receptor positive) but has stopped responding to past treatments. In Sub-Study B, all participants will take ARV-471 and ribociclib by mouth at home once a day. The study will monitor participants to see if the treatment is safe and effective. Participants will continue the treatment until their cancer stops responding or side effects become too severe, with clinic visits every four weeks.

Description

This study, part of the TACTIVE-U program, is a Phase 1b/2 trial to evaluate the safety and effectiveness of ARV-471 combined with ribociclib in people with advanced or metastatic breast cancer that is estrogen receptor positive and HER2 negative. The study is open-label, meaning both the researchers and participants know what treatment is being given. It is conducted at multiple centers and is part of a larger program that tests ARV-471 with different cancer treatments. ARV-471 is the main treatment, used with other drugs that may be effective for this type of breast cancer. Participants will take the study medicines at home and visit the clinic regularly to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic breast cancer that is estrogen receptor positive (ER+) and HER2 negative (HER2-), which cannot be fully treated with surgery.
  • Have had at least one, but no more than two, previous treatments for advanced or metastatic cancer.
  • Have received one treatment that included a CDK4/6 inhibitor.
  • Have at least one tumor that can be measured by scans.
  • Be in good overall health with a performance status score 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 other significant lung issues.
  • Have newly diagnosed or symptomatic brain metastases or other serious brain conditions.
  • Have had another type of cancer in the past three years, except for certain skin cancers or cervical cancer that has been treated.
  • Have inflammatory breast cancer.
  • Have significant heart problems or diseases.
  • Are taking medications, foods, or supplements that strongly affect certain liver enzymes or heart rhythms.
  • Have kidney problems, poor liver function, or inadequate bone marrow function.
  • Have an active infection.

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