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

NCT ID NCT05909397

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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