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NCT06125522 · 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 C)

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

Active
Registry status
Phase 1
Development phase
11
Enrollment target
20
Study locations

NCT06125522 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 11 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT06125522, 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
11 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to learn about the safety and effects of the study medicine called vepdegestrant. The safety and effects of vepdegestrant will be see when given with other medicines. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that: * is hard to treat (advanced) and may have spread to other organs (metastatic). is sensitive to hormonal therapy (it is called estrogen receptor positive). * is no longer responding to treatments taken before starting this study. This study is divided into separate sub-studies. For Sub-Study C: All the participants will receive vepdegestrant and a medicine called samuraciclib. Vepdegestrant and samuraciclib will be taken once in a day by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicine is safe and effective. Participant will continue to take vepdegestrant and samuraciclib 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 vepdegestrant
  • DRUG Samuraciclib

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
  • Barnes-Jewish Hospital - St Louis
  • Washington University School of Medicine - Siteman Cancer Center - St Louis
  • Siteman Cancer Center - South County - St Louis

Colorado

  • UCHealth Poudre Valley Hospital - Fort Collins
  • UCHealth Harmony - Fort Collins
  • UCHealth Greeley Hospital - Greeley
  • UCHealth - Medical Center of the Rockies - Loveland

Arkansas

  • Highlands Oncology Group - Fayetteville
  • Highlands Oncology Group - Rogers
  • Highlands Oncology Group - Springdale

California

  • Clinical and Translational Research Unit (CTRU) - Palo Alto
  • Stanford Cancer Center - Palo Alto

Illinois

  • Memorial Hospital East - Shiloh
  • Siteman Cancer Center - Shiloh - Shiloh

Bruxelles-capitale, Région de

  • Institut Jules Bordet - Anderlecht

Côte-d'or

  • Centre Georges François Leclerc - Dijon

Lombardy

  • Fondazione IRCCS San Gerardo dei Tintori - Monza

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2024-01-10
Est. Completion 2026-04-30
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 NCT06125522

The ClinicalTrials.gov registry entry for NCT06125522 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 11 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 (100% 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 vepdegestrant is the first listed.

NCT06125522 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Missouri, Colorado, Arkansas.

Frequently Asked Questions

What is clinical trial NCT06125522 about?

NCT06125522 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 C)". The purpose of this study is to learn about the safety and effects of the study medicine called vepdegestrant. The safety and effects of vepdegestrant will be see when given with other medicines. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer....

What is the current status of trial NCT06125522?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2024-01-10. Estimated completion is 2026-04-30.

What conditions does trial NCT06125522 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT06125522?

The interventions under investigation include: vepdegestrant (DRUG), Samuraciclib (DRUG).

Who is sponsoring clinical trial NCT06125522?

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

Where is trial NCT06125522 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Illinois, 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.