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)
Public ClinicalTrials.gov record NCT05548127. 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 Years and Over With ER+ Advanced or Metastatic Breast Cancer, Sub-study A (ARV-471 in Combination With Abemaciclib)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05548127
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 37 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
- Feb 22, 2023
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
- Last update posted
- Feb 9, 2026
2023 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 6
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Women's Cancer Center | Palo Alto | California | 94304 | — |
| UCSF Medical Center at Mission Bay | San Francisco | California | 94158 | — |
| Moffitt Cancer Center - International Plaza | Tampa | Florida | 33607 | — |
| Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center | Tampa | Florida | 33612 | — |
| Moffitt McKinley Hospital | Tampa | Florida | 33612 | — |
| Memorial Hospital | Shiloh | Illinois | 62269 | — |
| Siteman Cancer Center - Shiloh | Shiloh | Illinois | 62269 | — |
| Siteman Cancer Center - WUPI | 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 | — |
| Siteman Cancer Center | St Louis | Missouri | 63108 | — |
| 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 | — |
| U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376 | Houston | Texas | 77030 | — |
| U.T. MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Northwest Medical Specialties, PLLC | Bonney Lake | Washington | 98391 | — |
| Northwest Medical Specialties, PLLC | Federal Way | Washington | 98003 | — |
| Northwest Medical Specialties, PLLC | Gig Harbor | Washington | 98332 | — |
| Northwest Medical Specialties, PLLC | Puyallup | Washington | 98373 | — |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
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 15 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05548127, 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 Feb 9, 2026 · Synced Aug 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05548127 live on ClinicalTrials.gov.