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NCT05573555 · 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 B)

A Phase 1 study of Breast Cancer, sponsored by Pfizer.

Active
Registry status
Phase 1
Development phase
20
Enrollment target
20
Study locations

NCT05573555 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 20 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 5 states.

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The verdict

NCT05573555, 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
20 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 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.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Ribociclib
  • 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 Department of Laboratories - St Louis
  • Barnes-Jewish Hospital - St Louis
  • Washington University School of Medicine - Siteman Cancer Center - St Louis
  • Washington University School of Medicine - St Louis
  • Barnes Jewish Hospital Lab- South County - 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 Cancer Center - Tampa
  • Moffitt McKinley Hospital - Tampa

Massachusetts

  • Brigham and Women's Hospital - Boston
  • Dana-Farber Cancer Institute - Boston
  • Dana-Farber Cancer Institute - Chestnut Hill - Newton

California

  • Stanford Women's Cancer Center - Palo Alto
  • UCSF Medical Center at Mission Bay - San Francisco

Illinois

  • Siteman Cancer Center - WUPI - Shiloh

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2023-03-01
Est. Completion 2026-12-30
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05573555

The ClinicalTrials.gov registry entry for NCT05573555 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 20 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 Ribociclib is the first listed.

NCT05573555 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Missouri, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05573555 about?

NCT05573555 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 B)". 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 NCT05573555?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-03-01. Estimated completion is 2026-12-30.

What conditions does trial NCT05573555 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT05573555?

The interventions under investigation include: Ribociclib (DRUG), ARV-471 (DRUG).

Who is sponsoring clinical trial NCT05573555?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05573555 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.