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NCT05548127 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Breast Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 20
- Study locations
NCT05548127 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 37 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT05548127, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG ARV-471
Study Locations (20)
Missouri
- Siteman Cancer Center - St Peters - City of Saint Peters
- Siteman Cancer Center - West County - Creve Coeur
- Siteman Cancer Center - North County - Florissant
- Siteman Cancer Center - St Louis
- Barnes-Jewish Hospital - St Louis
- Washington University School of Medicine - Siteman Cancer Center - St Louis
- Washington University School of Medicine - St Louis
- Siteman Cancer Center - South County - St Louis
Florida
- Moffitt Cancer Center - International Plaza - Tampa
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center - Tampa
- Moffitt McKinley Hospital - Tampa
Illinois
- Memorial Hospital - Shiloh
- Siteman Cancer Center - Shiloh - Shiloh
- Siteman Cancer Center - WUPI - Shiloh
Texas
- U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376 - Houston
- U.T. MD Anderson Cancer Center - Houston
- University of Texas MD Anderson Cancer Center - Houston
California
- Stanford Women's Cancer Center - Palo Alto
- UCSF Medical Center at Mission Bay - San Francisco
Washington
- Northwest Medical Specialties, PLLC - Bonney Lake
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2023-02-23 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05548127
The ClinicalTrials.gov registry entry for NCT05548127 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Abemaciclib is the first listed.
NCT05548127 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Missouri, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05548127 about?
NCT05548127 is a clinical study titled "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)". 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 adva...
What is the current status of trial NCT05548127?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2023-02-23. Estimated completion is 2026-09-01.
What conditions does trial NCT05548127 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05548127?
The interventions under investigation include: Abemaciclib (DRUG), ARV-471 (DRUG).
Who is sponsoring clinical trial NCT05548127?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05548127 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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