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TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorPfizer
Started2023-02-23
View on ClinicalTrials.gov ↗
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: * is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy * is sensitive to hormonal therapy (it is called estrogen receptor positive); and * is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.

Amendment history 2 changes detected by DataLookout

2026-09-03
critical
Primary completion pushed: 2026-09-01 → 2027-03-24
2026-09-03
minor
Completion pushed: 2026-09-01 → 2027-03-24
Trial Details
NCT Number NCT05548127
Lead Sponsor Pfizer
Collaborators: Arvinas Estrogen Receptor, Inc.
Conditions Breast Cancer
Enrollment 37 participants
Start Date 2023-02-23
Primary Completion 2027-03-24 (estimated)
Study Completion 2027-03-24 (estimated)
Updated on ClinicalTrials.gov 2026-09-02