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)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group — Fayetteville, Arkansas
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 (21 Sites)
- Highlands Oncology Group — Fayetteville, Arkansas
- Highlands Oncology Group — Rogers, Arkansas
- Highlands Oncology Group — Springdale, Arkansas
- Clinical and Translational Research Unit (CTRU) — Palo Alto, California
- Stanford Women's Cancer Center — Palo Alto, California
- UCHealth Poudre Valley Hospital — Fort Collins, Colorado
- UCHealth Harmony — Fort Collins, Colorado
- UCHealth Greeley Hospital — Greeley, Colorado
- UCHealth - Medical Center of the Rockies — Loveland, Colorado
- Memorial Hospital East — Shiloh, Illinois
- Siteman Cancer Center - Shiloh — 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
- Barnes-Jewish Hospital — St Louis, Missouri
- Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri
- Siteman Cancer Center - South County — St Louis, Missouri
- Institut Jules Bordet — Anderlecht, Bruxelles-capitale, Région de
- Centre Georges François Leclerc — Dijon, Côte-d'or
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Lombardy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore — Roma,
💰 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.
More studies in Breast Cancer
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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.