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New hope for advanced breast cancer: drug combo targets tumors after hormone therapy fails

NCT ID NCT06428396

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 2 times

Summary

This study tests whether adding belzutifan to fulvestrant can slow or stop the growth of a certain type of advanced breast cancer (ER+/HER2-) that has worsened despite hormone therapy. About 120 adults with inoperable or metastatic disease will receive either the new combination or standard treatment. The goal is to see if the new approach delays cancer progression.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2028

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: * Has a diagnosis of estrogen receptor positive (ER+)/human epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent * Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET) * Provides additional tissue from the same sample used to determine ER and HER2 status locally * Has received ET in the noncurative setting and has 1) Radiographic disease progression on 12 months or more of ET in combination with CDK4/6 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4/6 inhibitor where the CDK 4/6 inhibitor was discontinued due to intolerance * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization Exclusion Criteria: * Has Breast cancer amenable to treatment with curative intent * Is unable to receive any of the endocrine therapies (ETs) (ie, fulvestrant or exemestane) * Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications such as uncontrolled nausea or vomiting (ie, CTCAE =Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction, motility disorder, malabsorption syndrome, or prior gastric bypass * Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications * Has active, bleeding diathesis, or on oral anti-vitamin K medication * Has history of noninfectious pneumonitis/interstitial lung disease including radiation pneumonitis that required steroids or has current pneumonitis/interstitial lung disease * Has a known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition either in the adjuvant or metastatic setting * Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting * Has received any line of cytotoxic chemotherapy or PARP inhibitor in the unresectable or noncurative advanced/metastatic setting * Has received prior radiotherapy for non-central nervous system (CNS) disease or required corticosteroids for radiation-related toxicities including radiation pneumonitis, within 14 days of the first dose of study intervention * Is currently receiving either a strong inhibitor or inducer of CYP3A4 that cannot be discontinued for the duration of the study * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has concurrent active Hepatitis B and Hepatitis C virus infection * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or Class IV congestive heart failure * Has not adequately recovered from major surgery or have ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm estrogen-receptor positive breast cancer

As listed by the trial registrant

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

Metastatic breast cancer

Contacts and locations

Locations

  • Bradfordhill ( Site 4100)

    Santiago, Region M. de Santiago, 8420383, Chile

  • CHRISTUS Highland ( Site 0005)

    Shreveport, Louisiana, 71105, United States

  • Cedars Sinai Medical Center ( Site 0012)

    Beverly Hills, California, 90211, United States

  • Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504)

    CABA, Buenos Aires, C1056ABI, Argentina

  • Centro de Investigación del Maule ( Site 4106)

    Talca, Maule Region, 3460000, Chile

  • City of Hope - Phoenix ( Site 0006)

    Goodyear, Arizona, 85338, United States

  • FALP ( Site 4102)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine - Khon Kaen University ( Site 3502)

    Muang, Changwat Khon Kaen, 40002, Thailand

  • Faculty of Medicine Siriraj Hospital ( Site 3500)

    Bangkoknoi, Bangkok, 10700, Thailand

  • Fundacion Valle del Lili ( Site 1204)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Hospital Británico de Buenos Aires-Oncology ( Site 0500)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

  • Hospital Italiano de Córdoba ( Site 0508)

    Córdoba, X5004BAL, Argentina

  • IMAT S.A.S ( Site 1205)

    Montería, Departamento de Córdoba, 230002, Colombia

  • Instituto Alexander Fleming-Alexander Fleming ( Site 0505)

    Buenos Aires, Buenos Aires F.D., C1426ANZ, Argentina

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502)

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Instituto de Oncología de Rosario ( Site 0501)

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Ipswich Hospital ( Site 1911)

    Ipswich, Suffolk, IP4 5PD, United Kingdom

  • Jewish General Hospital ( Site 0400)

    Montreal, Quebec, H3T 1E2, Canada

  • MD Anderson ( Site 0015)

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center at Cooper ( Site 0024)

    Camden, New Jersey, 08103, United States

  • Mays Cancer Center ( Site 0022)

    San Antonio, Texas, 78229, United States

  • Medical College of Wisconsin - Froedtert Hospital ( Site 0014)

    Milwaukee, Wisconsin, 53226, United States

  • Moores Cancer Center at UC San Diego Health ( Site 0025)

    La Jolla, California, 92093, United States

  • National Cheng Kung University Hospital ( Site 3300)

    Tainan, 704302, Taiwan

  • National Taiwan University Cancer Center ( Site 3302)

    Taipei, 106, Taiwan

  • National Taiwan University Hospital ( Site 3301)

    Taipei, 10002, Taiwan

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)

    Marietta, Georgia, 30060, United States

  • Oncologos Del Occidente ( Site 1200)

    Pereira, Risaralda Department, 660001, Colombia

  • Pontificia Universidad Catolica de Chile ( Site 4108)

    Santiago, Region M. de Santiago, 8330024, Chile

  • Renown Regional Medical Center ( Site 0018)

    Reno, Nevada, 89502, United States

  • SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034)

    Madison, Wisconsin, 53715, United States

  • Samsung Medical Center ( Site 3101)

    Seoul, 06351, South Korea

  • Sanatorio Allende - Cerro-Oncology ( Site 0506)

    Córdoba, Córdoba Province, 5000, Argentina

  • Seoul National University Hospital ( Site 3100)

    Seoul, 03080, South Korea

  • Songklanagarind Hospital ( Site 3501)

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Southeastern Regional Medical Center ( Site 0010)

    Newnan, Georgia, 30265, United States

  • St Bartholomews Hospital ( Site 1900)

    London, London, City of, EC1A 7BE, United Kingdom

  • The Christie Hospital NHS Foundation Trust ( Site 1902)

    Withington, Manchester, M20 4BX, United Kingdom

  • The Royal Cornwall Hospital ( Site 1904)

    Truro, England, TR1 3LJ, United Kingdom

  • USC Norris Oncology Hematology Newport Beach ( Site 0029)

    Newport Beach, California, 92663, United States

  • USC/Norris Comprehensive Cancer Center ( Site 0013)

    Los Angeles, California, 90033, United States

More trials for these conditions

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