Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer (NCT05909397)
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF VEPDEGESTRANT (ARV-471/PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to understand the safety and effects of the study medicine vepdegestrant (ARV-471/PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of vepdegestrant plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. Vepdegestrant is a new medicine under study. This study is seeking participants who have breast cancer that: * Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. * Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. * Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with vepdegestrant will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with vepdegestrant. In the Phase 3, half of the participants will take vepdegestrant plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.
Who can join: Review the eligibility criteria below.
Location: BRCR Global — Plantation, Florida
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 (29 Sites)
Showing the first 25 of 29 sites.
- BRCR Global — Plantation, Florida
- BRCR Medical Center Inc — Plantation, Florida
- Virginia Oncology Associates — Norfolk, Virginia
- Cancer Research SA — Adelaide, South Australia
- Barwon Health — Geelong, Victoria
- Hospital Santa Rita de Cassia — Vitória, Espírito Santo
- Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa — Porto Alegre, Rio Grande do Sul
- Centro de Pesquisa Clínica - Área Administrativa — Porto Alegre, Rio Grande do Sul
- Hospital Mae de Deus — Porto Alegre, Rio Grande do Sul
- Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong
- Hubei Cancer Hospital — Wuhan, Hubei
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi
- Debreceni Egyetem Klinikai Kozpont — Debrecen,
- Istituto Nazionale Tumori IRCCS Fondazione Pascale — Naples, Campania
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola, Emilia-Romagna
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Lombardy
- Aichi Cancer Center Hospital — Nagoya, Aichi-ken
- National Cancer Center Hospital East — Kashiwa, Chiba
- National Cancer Center Hospital — Chuo-ku, Tokyo
- Nemocnica na okraji mesta n o — Partizánske,
- Fakultna nemocnica s poliklinikou J.A. Reimana Presov — Prešov,
- Institut Català d'Oncologia (ICO) - Badalona — Badalona, Barcelona [barcelona]
- Hospital Universitari Dexeus — Barcelona, Catalunya [cataluña]
- Complejo Hospitalario de Jaén — Jaén, JAÉN
💰 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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💡 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.