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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 27, 2024

Primary Completion Date

May 5, 2027

Study Completion Date

October 7, 2028

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Belzutifan

Belzutifan 120 mg administered QD as an oral tablet.

DRUG

Fulvestrant

Fulvestrant 500 mg administered as an IM injection.

DRUG

Everolimus

Administered at 10mg via oral tablets QD.

DRUG

Exemestane

Administered at 25 mg via oral tablets QD.

Trial Locations (39)

100

RECRUITING

National Taiwan University Hospital ( Site 3301), Taipei

106

RECRUITING

National Taiwan University Cancer Center ( Site 3302), Taipei

5000

RECRUITING

Sanatorio Allende - Cerro-Oncology ( Site 0506), Córdoba

10700

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 3500), Bangkoknoi

30060

COMPLETED

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

30265

RECRUITING

Southeastern Regional Medical Center ( Site 0010), Newnan

40002

RECRUITING

Faculty of Medicine - Khon Kaen University ( Site 3502), Muang

53226

RECRUITING

Medical College of Wisconsin - Froedtert Hospital ( Site 0014), Milwaukee

53715

RECRUITING

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

71105

RECRUITING

CHRISTUS Highland ( Site 0005), Shreveport

77030

RECRUITING

MD Anderson ( Site 0015), Houston

78229

RECRUITING

Mays Cancer Center ( Site 0022), San Antonio

85338

RECRUITING

City of Hope - Phoenix ( Site 0006), Goodyear

89502

RECRUITING

Renown Regional Medical Center ( Site 0018), Reno

90033

RECRUITING

USC/Norris Comprehensive Cancer Center ( Site 0013), Los Angeles

90110

RECRUITING

Songklanagarind Hospital ( Site 3501), Hat Yai

90211

RECRUITING

Cedars Sinai Medical Center ( Site 0012), Beverly Hills

92093

RECRUITING

Moores Cancer Center at UC San Diego Health ( Site 0025), La Jolla

92663

RECRUITING

USC Norris Oncology Hematology Newport Beach ( Site 0029), Newport Beach

230002

RECRUITING

IMAT S.A.S ( Site 1205), Montería

660001

RECRUITING

Oncologos Del Occidente ( Site 1200), Pereira

704302

RECRUITING

National Cheng Kung University Hospital ( Site 3300), Tainan City

760032

RECRUITING

Fundacion Valle del Lili ( Site 1204), Santiago de Cali

3460000

RECRUITING

Centro de Investigación del Maule ( Site 4106), Talca

7500921

RECRUITING

FALP ( Site 4102), Santiago

8330024

RECRUITING

Pontificia Universidad Catolica de Chile ( Site 4108), Santiago

8420383

RECRUITING

Bradfordhill ( Site 4100), Santiago

C1056ABI

RECRUITING

Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504), CABA

C1280AEB

RECRUITING

Hospital Británico de Buenos Aires-Oncology ( Site 0500), Ciudad Autónoma de Buenos Aires

B7600FZO

RECRUITING

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

1426ANZ

RECRUITING

Instituto Alexander Fleming-Alexander Fleming ( Site 0505), Buenos Aires

S2000KZE

RECRUITING

Instituto de Oncología de Rosario ( Site 0501), Rosario

H3T 1E2

RECRUITING

Jewish General Hospital ( Site 0400), Montreal

03080

RECRUITING

Seoul National University Hospital ( Site 3100), Seoul

06351

RECRUITING

Samsung Medical Center ( Site 3101), Seoul

TR1 3LJ

RECRUITING

The Royal Cornwall Hospital ( Site 1904), Truro

EC1A 7BE

RECRUITING

St Bartholomews Hospital ( Site 1900), London

M20 4BX

RECRUITING

The Christie Hospital NHS Foundation Trust ( Site 1902), Withington

IP4 5PD

RECRUITING

Ipswich Hospital ( Site 1911), Ipswich

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT06428396 - Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) | Biotech Hunter | Biotech Hunter