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) (NCT05548127)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Stanford Women's Cancer Center — Palo Alto, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (39 Sites)
Showing the first 25 of 39 sites.
- Stanford Women's Cancer Center — Palo Alto, California
- UCSF Medical Center at Mission Bay — San Francisco, California
- Moffitt Cancer Center - International Plaza — Tampa, Florida
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center — Tampa, Florida
- Moffitt McKinley Hospital — Tampa, Florida
- Memorial Hospital — Shiloh, Illinois
- Siteman Cancer Center - Shiloh — Shiloh, Illinois
- Siteman Cancer Center - WUPI — Shiloh, Illinois
- Siteman Cancer Center - St Peters — City of Saint Peters, Missouri
- Siteman Cancer Center - West County — Creve Coeur, Missouri
- Siteman Cancer Center - North County — Florissant, Missouri
- Siteman Cancer Center — St Louis, Missouri
- Barnes-Jewish Hospital — St Louis, Missouri
- Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Siteman Cancer Center - South County — St Louis, Missouri
- U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376 — Houston, Texas
- U.T. MD Anderson Cancer Center — Houston, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas
- Northwest Medical Specialties, PLLC — Bonney Lake, Washington
- Northwest Medical Specialties, PLLC — Federal Way, Washington
- Northwest Medical Specialties, PLLC — Gig Harbor, Washington
- Northwest Medical Specialties, PLLC — Puyallup, Washington
- Northwest Medical Specialties, PLLC — Tacoma, Washington
- BC Cancer Vancouver — Vancouver, British Columbia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
- Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
- 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) — Palo Alto, California
- A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer — Chicago, Illinois
- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.