A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
City of Hope - Phoenix ( Site 0006)
RECRUITING
Goodyear
California
Cedars Sinai Medical Center ( Site 0012)
RECRUITING
Beverly Hills
Moores Cancer Center at UC San Diego Health ( Site 0025)
RECRUITING
La Jolla
USC/Norris Comprehensive Cancer Center ( Site 0013)
RECRUITING
Los Angeles
USC Norris Oncology Hematology Newport Beach ( Site 0029)
RECRUITING
Newport Beach
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)
COMPLETED
Marietta
Southeastern Regional Medical Center ( Site 0010)
RECRUITING
Newnan
Louisiana
CHRISTUS Highland ( Site 0005)
RECRUITING
Shreveport
Nevada
Renown Regional Medical Center ( Site 0018)
RECRUITING
Reno
Texas
MD Anderson ( Site 0015)
RECRUITING
Houston
Mays Cancer Center ( Site 0022)
RECRUITING
San Antonio
Wisconsin
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034)
RECRUITING
Madison
Medical College of Wisconsin - Froedtert Hospital ( Site 0014)
RECRUITING
Milwaukee
Other Locations
Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 0505)
RECRUITING
Buenos Aires
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504)
RECRUITING
Caba
Hospital Británico de Buenos Aires-Oncology ( Site 0500)
RECRUITING
Ciudad Autónoma De Buenos Aires
Sanatorio Allende - Cerro-Oncology ( Site 0506)
RECRUITING
Córdoba
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502)
RECRUITING
Mar Del Plata
Instituto de Oncología de Rosario ( Site 0501)
RECRUITING
Rosario
Canada
Jewish General Hospital ( Site 0400)
RECRUITING
Montreal
Chile
Bradfordhill ( Site 4100)
RECRUITING
Santiago
FALP ( Site 4102)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 4108)
RECRUITING
Santiago
Centro de Investigación del Maule ( Site 4106)
RECRUITING
Talca
Colombia
IMAT S.A.S ( Site 1205)
RECRUITING
Montería
Oncologos Del Occidente ( Site 1200)
RECRUITING
Pereira
Fundacion Valle del Lili ( Site 1204)
RECRUITING
Santiago De Cali
Republic of Korea
Samsung Medical Center ( Site 3101)
RECRUITING
Seoul
Seoul National University Hospital ( Site 3100)
RECRUITING
Seoul
Taiwan
National Cheng Kung University Hospital ( Site 3300)
RECRUITING
Tainan City
National Taiwan University Cancer Center ( Site 3302)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 3301)
RECRUITING
Taipei
Thailand
Faculty of Medicine Siriraj Hospital ( Site 3500)
RECRUITING
Bangkoknoi
Songklanagarind Hospital ( Site 3501)
RECRUITING
Hat Yai
Faculty of Medicine - Khon Kaen University ( Site 3502)
RECRUITING
Muang
United Kingdom
Ipswich Hospital ( Site 1911)
RECRUITING
Ipswich
St Bartholomews Hospital ( Site 1900)
RECRUITING
London
The Royal Cornwall Hospital ( Site 1904)
RECRUITING
Truro
The Christie Hospital NHS Foundation Trust ( Site 1902)
RECRUITING
Withington
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date:2024-11-27
Estimated Completion Date:2028-10-07
Participants
Target number of participants:120
Treatments
Experimental: Belzutifan + Fulvestrant
Participants will receive belzutifan 120 mg orally once daily (QD) PLUS fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until progressive disease or discontinuation.
Active_comparator: Everolimus + ET (fulvestrant or exemestane)
Participants will receive everolimus 10 mg orally QD PLUS investigator's choice of fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter OR exemestane 25 mg orally QD until progressive disease or discontinuation.
Who is this study for: Patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative locally advanced, unresectable or metastatic breast cancer
Enrollment Status: Recruiting
Publish Date: September 17, 2025
Intervention Type: Drug
Study Drugs: Capivasertib, Fulvestrant, Palbociclib