Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-free Survival (PFS) — Up to approximately 29 months
PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Egypt
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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 Egypt