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)
Public ClinicalTrials.gov record NCT06125522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06125522
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 11 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 10, 2024 (Actual)
- Primary completion
- Sep 10, 2026 (Actual)
- Completion
- Sep 10, 2026 (Actual)
- Last update posted
- Oct 2, 2026
2024 – 2026
United States locations
- U.S. sites
- 19
- U.S. states
- 5
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| Highlands Oncology Group | Rogers | Arkansas | 72758 | — |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | — |
| Clinical and Translational Research Unit (CTRU) | Palo Alto | California | 94304 | — |
| Stanford Cancer Institute - Clinical Trials Office | Palo Alto | California | 94304 | — |
| Stanford Women's Cancer Center | Palo Alto | California | 94304 | — |
| UCHealth Poudre Valley Hospital | Fort Collins | Colorado | 80524 | — |
| UCHealth Harmony | Fort Collins | Colorado | 80528 | — |
| UCHealth Greeley Hospital | Greeley | Colorado | 80634 | — |
| UCHealth - Medical Center of the Rockies | Loveland | Colorado | 80538 | — |
| Memorial Hospital East | Shiloh | Illinois | 62269 | — |
| Siteman Cancer Center - Shiloh | Shiloh | Illinois | 62269 | — |
| Siteman Cancer Center - St Peters | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | — |
| Siteman Cancer Center - North County | Florissant | Missouri | 63031 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine - Siteman Cancer Center | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06125522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06125522 live on ClinicalTrials.gov.