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

NCT ID NCT05909397

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

59 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment * Confirmed diagnosis of ER+/HER2- breast cancer * No prior systemic treatment for loco-regional recurrent or metastatic disease * Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Phase 3 only: Participants should be willing to provide blood and tumor tissue Exclusion Criteria: * Disease recurrence while on, or within 12 months of completion of adjuvant endocrine therapy * Prior treatment with cyclin dependent kinase 4/6 inhibitors (CDK4/6i), vepdegestrant, fulvestrant, elacestrant and other investigational drugs including novel endocrine therapies, any selective estrogen receptor degraders (SERDs), covalent antagonists (SERCAs) and complete ER antagonists (CERANs). * Inadequate liver, kidney and bone marrow function * Impaired cardiovascular function or clinically significant cardiovascular diseases * Refractory nausea and vomiting, inability to swallow capsules and tablets whole, chronic gastrointestinal diseases, significant gastric (total or partial) or bowel resection that would preclude adequate absorption of study interventions. * Current use or anticipated need for food, herbal supplements or drugs that are known strong CYP3A4 inhibitors or inducers.

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.