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New pill cocktail aims to control Hard-to-Treat breast cancer

NCT ID NCT05548127

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tests a new oral drug, vepdegestrant, combined with abemaciclib in people with advanced or metastatic ER+ breast cancer that no longer responds to prior treatments. About 37 adults will take both pills daily at home, with clinic visits every 4 weeks, to see if the combination is safe and can shrink tumors or slow disease progression. The goal is disease control, not a cure, as ongoing treatment is needed.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

37 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Mar 2027

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: * histological or cytological diagnosis of ER+ and HER2- advanced/metastatic breast cancer that is not amendable to surgical resection with curative intent (≥1% ER+ stained cells on the most recent tumor biopsy). * prior anticancer therapies: at least 1 and no more than 2 lines of prior therapies for advanced/metastatic disease; 1 line of any CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/metastatic) * at least 1 measurable lesion as defined by RECIST v1.1. * ECOG PS ≤1. Exclusion Criteria: * visceral crisis at risk of life-threatening complications in the short term * known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions. * newly diagnosed brain metastases, or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated, clinically stable and discontinued anti-seizure medications and corticosteroids for at least 14 days prior to enrollment in the study. * history of any other tumor malignancies within the past 3 years, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated in situ carcinoma of the cervix. * inflammatory breast cancer * impaired cardiovascular function or clinically significant cardiovascular diseases * concurrent administration of medications, food, or herb supplements that are strong inhibitors and strong/moderate inducers of CYP3A and drugs known to predispose to Torsade de Pointes or QT interval prolongation. * renal impairment, not adequate liver function and/or bone marrow function * known active infection

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-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

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 1H7, Canada

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6, Canada

  • Clinica Universidad de Navarra

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Rome, Lazio, 00168, Italy

  • Hospital Universitari Dexeus

    Barcelona, Catalunya [cataluña], 08028, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060, Italy

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Memorial Hospital

    Shiloh, Illinois, 62269, United States

  • Moffitt Cancer Center - International Plaza

    Tampa, Florida, 33607, United States

  • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

    Tampa, Florida, 33612, United States

  • Moffitt McKinley Hospital

    Tampa, Florida, 33612, United States

  • Northwest Medical Specialties, PLLC

    Bonney Lake, Washington, 98391, United States

  • Northwest Medical Specialties, PLLC

    Federal Way, Washington, 98003, United States

  • Northwest Medical Specialties, PLLC

    Gig Harbor, Washington, 98332, United States

  • Northwest Medical Specialties, PLLC

    Puyallup, Washington, 98373, United States

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Siteman Cancer Center

    St Louis, Missouri, 63108, United States

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031, United States

  • Siteman Cancer Center - Shiloh

    Shiloh, Illinois, 62269, United States

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129, United States

  • Siteman Cancer Center - St Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141, United States

  • Stanford Women's Cancer Center

    Palo Alto, California, 94304, United States

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • U.T. MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376

    Houston, Texas, 77030, United States

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

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