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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)
NCT06125522 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2024-01-10 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06125522 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Missouri, Colorado, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06125522?
The interventions under investigation include: vepdegestrant (DRUG), Samuraciclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06125522?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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