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Clinical Trials in the UK / NCT06428396
Active, not recruiting Phase 2

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

NCT06428396 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2024-11-27
Last updated
2026-08-28

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

BelzutifanFulvestrantEverolimusExemestane

Belzutifan: Belzutifan 120 mg administered QD as an oral tablet.

Fulvestrant: Fulvestrant 500 mg administered as an IM injection.

Everolimus: Administered at 10mg via oral tablets QD.

Exemestane: Administered at 25 mg via oral tablets QD.

Study summary

The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
City of Hope - Phoenix ( Site 0006) Goodyear Arizona
Cedars Sinai Medical Center ( Site 0012) Beverly Hills California
Moores Cancer Center at UC San Diego Health ( Site 0025) La Jolla California
USC/Norris Comprehensive Cancer Center ( Site 0013) Los Angeles California
USC Norris Oncology Hematology Newport Beach ( Site 0029) Newport Beach California
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011) Marietta Georgia
Southeastern Regional Medical Center ( Site 0010) Newnan Georgia
CHRISTUS Highland ( Site 0005) Shreveport Louisiana
Renown Regional Medical Center ( Site 0018) Reno Nevada
MD Anderson Cancer Center at Cooper ( Site 0024) Camden New Jersey
MD Anderson ( Site 0015) Houston Texas
Mays Cancer Center ( Site 0022) San Antonio Texas
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034) Madison Wisconsin
Medical College of Wisconsin - Froedtert Hospital ( Site 0014) Milwaukee Wisconsin
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504) CABA Buenos Aires
Hospital Británico de Buenos Aires-Oncology ( Site 0500) Ciudad Autónoma de Buenos Aires Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502) Mar del Plata Buenos Aires
Instituto Alexander Fleming-Alexander Fleming ( Site 0505) Buenos Aires Buenos Aires F.D.
Sanatorio Allende - Cerro-Oncology ( Site 0506) Córdoba Córdoba Province
Instituto de Oncología de Rosario ( Site 0501) Rosario Santa Fe Province
Hospital Italiano de Córdoba ( Site 0508) Córdoba Argentina
Jewish General Hospital ( Site 0400) Montreal Quebec
Centro de Investigación del Maule ( Site 4106) Talca Maule Region
FALP ( Site 4102) Santiago Region M. de Santiago
Pontificia Universidad Catolica de Chile ( Site 4108) Santiago Region M. de Santiago
Bradfordhill ( Site 4100) Santiago Region M. de Santiago
IMAT S.A.S ( Site 1205) Montería Departamento de Córdoba
Oncologos Del Occidente ( Site 1200) Pereira Risaralda Department
Fundacion Valle del Lili ( Site 1204) Cali Valle del Cauca Department
Seoul National University Hospital ( Site 3100) Seoul South Korea
Samsung Medical Center ( Site 3101) Seoul South Korea
National Cheng Kung University Hospital ( Site 3300) Tainan Taiwan
National Taiwan University Hospital ( Site 3301) Taipei Taiwan
National Taiwan University Cancer Center ( Site 3302) Taipei Taiwan
Faculty of Medicine Siriraj Hospital ( Site 3500) Bangkoknoi Bangkok
Faculty of Medicine - Khon Kaen University ( Site 3502) Muang Changwat Khon Kaen
Songklanagarind Hospital ( Site 3501) Hat Yai Changwat Songkhla
The Royal Cornwall Hospital ( Site 1904) Truro England
St Bartholomews Hospital ( Site 1900) London London, City of
The Christie Hospital NHS Foundation Trust ( Site 1902) Withington Manchester

+ 1 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06428396 on ClinicalTrials.gov ↗ ← All trials in the UK