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 B)

ACTIVE NOT RECRUITING

NCT05573555

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 B: All participants will receive ARV-471 and a medicine called ribociclib. ARV-471 and ribociclib will be given at the same time by mouth, at home, 1 time a day. The experiences of people receiving the study medicine will be examined. This will help determine if the study medicine is safe and effective. Participants will continue to take ARV-471 and ribociclib 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 B (ARV-471 IN COMBINATION WITH RIBOCICLIB)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-03-01

Completion Date

2026-12-30

Last Updated

2026-03-09

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 RP2D determined, cycles lasting 28 days

DRUG

Ribociclib

Daily oral dosages of ribociclib consecutively for 21 days followed by 7 days off treatment, cycles lasting 28 days

Locations (29)

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 Cancer Center

Tampa, Florida, United States

Moffitt McKinley Hospital

Tampa, Florida, United States

Siteman Cancer Center - WUPI

Shiloh, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts, 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