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New drug combo aims to control advanced breast cancer

NCT ID NCT05573555

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new oral drug, ARV-471, combined with ribociclib in adults with advanced or metastatic ER+ breast cancer that has stopped responding to previous treatments. The goal is to see if the combination is safe and can shrink tumors or slow cancer growth. Participants take both pills daily at home and visit the clinic every 4 weeks.

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

20 people

The number who actually took part.

Started

Mar 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: * 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, and only 1, line of any CDK4/6 inhibitor-based regimen is required (in any setting eg adjuvant, 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 of 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 Department of Laboratories

    St Louis, Missouri, 63110, United States

  • Barnes Jewish Hospital Lab- South County

    St Louis, Missouri, 63129, United States

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6, Canada

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02459, United States

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy, 20900, Italy

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Moffitt Cancer Center

    Tampa, Florida, 33612, 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

  • Siteman Cancer Center

    St Louis, Missouri, 63108, United States

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031, 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 - WUPI

    Shiloh, Illinois, 62269, 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

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158, 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

More trials for these conditions

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