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)

ACTIVE NOT RECRUITING

NCT05548127

PHASE1/PHASE2

Sponsor: Pfizer

Summary

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.

Official title: TACTIVE-U: An Interventional Safety and Efficacy Phase 1b/2, Open-label Umbrella Study to Investigate Tolerability, pk, and Antitumor Activity of Vepdegestrant (ARV-471/PF-07850327), an Oral Proteolysis Targeting Chimera, in Combination With Other Anticancer Treatments in Participants Aged 18 Years and Over With ER+ Advanced or Metastatic Breast Cancer, Sub-study A (ARV-471 in Combination With Abemaciclib)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2023-02-23

Completion Date

2026-09-01

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Breast Cancer

Interventions

DRUG

ARV-471

Daily oral dosages of ARV-471 continuously, dose escalation/de-escalation in Phase 1b until the recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

DRUG

Abemaciclib

Daily oral dosages of Abemaciclib continuously, cycles lasting 28 days

Locations (39)

Stanford Women's Cancer Center

Palo Alto, California, United States

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Moffitt Cancer Center - International Plaza

Tampa, Florida, United States

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, United States

Moffitt McKinley Hospital

Tampa, Florida, United States

Memorial Hospital

Shiloh, Illinois, United States

Siteman Cancer Center - Shiloh

Shiloh, Illinois, United States

Siteman Cancer Center - WUPI

Shiloh, Illinois, United States

Siteman Cancer Center - St Peters

City of Saint Peters, Missouri, United States

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

Siteman Cancer Center - North County

Florissant, Missouri, United States

Siteman Cancer Center

St Louis, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center - South County

St Louis, Missouri, United States

U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376

Houston, Texas, United States

U.T. MD Anderson Cancer Center

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States