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)
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT05573555. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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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 B (ARV-471 IN COMBINATION WITH RIBOCICLIB)
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 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.
Study identification
- NCT ID
- NCT05573555
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 20 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
- Mar 1, 2023 (Actual)
- Primary completion
- Oct 6, 2026 (Actual)
- Completion
- Oct 6, 2026 (Actual)
- Last update posted
- Oct 27, 2026
2023 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 5
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| 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 Cancer Center | Tampa | Florida | 33612 | — |
| Moffitt McKinley Hospital | Tampa | Florida | 33612 | — |
| Siteman Cancer Center - WUPI | Shiloh | Illinois | 62269 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute - Chestnut Hill | Newton | Massachusetts | 02459 | — |
| 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 Department of Laboratories | St Louis | Missouri | 63110 | — |
| 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 | — |
| Barnes Jewish Hospital Lab- South County | St Louis | Missouri | 63129 | — |
| 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 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05573555, 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 27, 2026 · Synced Nov 12, 2026
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