New breast cancer pill combo shows promise in Late-Stage trial

NCT ID NCT05909397

Ongoing Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a new experimental drug, vepdegestrant, combined with palbociclib against the standard treatment (letrozole plus palbociclib) for people with advanced ER+/HER2- breast cancer that has not been treated before. The study aims to see if the new combination works better at stopping the cancer from growing. Participants take pills by mouth daily until the cancer worsens or side effects become too severe.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Vepdegestrant (ARV-471) plus palbociclib
What this could lead to: If successful, this could offer a new first-line treatment option for people with advanced ER+/HER2- breast cancer, potentially delaying disease progression.
What could go wrong: This is an early-stage study lead-in before the main Phase 3, so results are preliminary. The new drug may not prove more effective than the current standard, and side effects like low white blood cell counts are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER

Contacts and locations

Locations

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan
BRCR Global

Plantation, Florida, 33322, United States
BRCR Medical Center Inc

Plantation, Florida, 33322, United States
Barwon Health

Geelong, Victoria, 3220, Australia
Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China
Cancer Research SA

Adelaide, South Australia, 5000, Australia
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Centro de Pesquisa Clínica - Área Administrativa

Porto Alegre, Rio Grande do Sul, 90850-170, Brazil
Complejo Hospitalario de Jaén

Jaén, JAÉN, 23007, Spain
Debreceni Egyetem Klinikai Kozpont

Debrecen, 04032, Hungary
Fakultna nemocnica s poliklinikou J.A. Reimana Presov

Prešov, 080 01, Slovakia
Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy
Hospital Clinico San Carlos

Madrid, 28040, Spain
Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
Hospital Santa Rita de Cassia

Vitória, Espírito Santo, 29043-260, Brazil
Hospital Universitari Dexeus

Barcelona, Catalunya [cataluña], 08028, Spain
Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain
Hospital Unviersitario Virgen Nieves

Granada, 18012, Spain
Hubei Cancer Hospital

Wuhan, Hubei, 430079, China
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, 47014, Italy
Institut Català d'Oncologia (ICO) - Badalona

Badalona, Barcelona [barcelona], 08916, Spain
Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Campania, 80131, Italy
National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan
National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan
Nemocnica na okraji mesta n o

Partizánske, 95801, Slovakia
Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China
Tumor Zentrum Aarau

Aarau, Canton of Aargau, 5000, Switzerland
Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

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