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Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
NCT06428396 · Merck Sharp & Dohme LLC
In plain English
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Official title
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)
About this study
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 criteria
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
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-27
Estimated completion: 2028-10-07
Last updated: 2026-03-24
Interventions
Drug: BelzutifanDrug: FulvestrantDrug: EverolimusDrug: Exemestane
Primary outcomes
- • Progression-free Survival (PFS) (Up to approximately 29 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (41)
City of Hope - Phoenix ( Site 0006)Recruiting
Goodyear, Arizona, United States
Cedars Sinai Medical Center ( Site 0012)Recruiting
Beverly Hills, California, United States
Moores Cancer Center at UC San Diego Health ( Site 0025)Recruiting
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center ( Site 0013)Recruiting
Los Angeles, California, United States
USC Norris Oncology Hematology Newport Beach ( Site 0029)Recruiting
Newport Beach, California, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)Completed
Marietta, Georgia, United States
Southeastern Regional Medical Center ( Site 0010)Recruiting
Newnan, Georgia, United States
CHRISTUS Highland ( Site 0005)Completed
Shreveport, Louisiana, United States
Renown Regional Medical Center ( Site 0018)Recruiting
Reno, Nevada, United States
MD Anderson Cancer Center at Cooper ( Site 0024)Recruiting
Camden, New Jersey, United States
MD Anderson ( Site 0015)Recruiting
Houston, Texas, United States
Mays Cancer Center ( Site 0022)Recruiting
San Antonio, Texas, United States
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034)Recruiting
Madison, Wisconsin, United States
Medical College of Wisconsin - Froedtert Hospital ( Site 0014)Recruiting
Milwaukee, Wisconsin, United States
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504)Recruiting
CABA, Buenos Aires, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0500)Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502)Recruiting
Mar del Plata, Buenos Aires, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 0505)Recruiting
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Allende - Cerro-Oncology ( Site 0506)Recruiting
Córdoba, Córdoba Province, Argentina
Instituto de Oncología de Rosario ( Site 0501)Recruiting
Rosario, Santa Fe Province, Argentina
Hospital Italiano de Córdoba ( Site 0508)Recruiting
Córdoba, Argentina
Jewish General Hospital ( Site 0400)Recruiting
Montreal, Quebec, Canada
Centro de Investigación del Maule ( Site 4106)Recruiting
Talca, Maule Region, Chile
FALP ( Site 4102)Recruiting
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 4108)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 4100)Recruiting
Santiago, Region M. de Santiago, Chile
IMAT S.A.S ( Site 1205)Recruiting
Montería, Departamento de Córdoba, Colombia
Oncologos Del Occidente ( Site 1200)Recruiting
Pereira, Risaralda Department, Colombia
Fundacion Valle del Lili ( Site 1204)Recruiting
Cali, Valle del Cauca Department, Colombia
Seoul National University Hospital ( Site 3100)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 3101)Recruiting
Seoul, South Korea
National Cheng Kung University Hospital ( Site 3300)Recruiting
Tainan, Taiwan
National Taiwan University Hospital ( Site 3301)Recruiting
Taipei, Taiwan
National Taiwan University Cancer Center ( Site 3302)Recruiting
Taipei, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 3500)Recruiting
Bangkoknoi, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University ( Site 3502)Recruiting
Muang, Changwat Khon Kaen, Thailand
Songklanagarind Hospital ( Site 3501)Recruiting
Hat Yai, Changwat Songkhla, Thailand
The Royal Cornwall Hospital ( Site 1904)Recruiting
Truro, England, United Kingdom
St Bartholomews Hospital ( Site 1900)Recruiting
London, London, City of, United Kingdom
The Christie Hospital NHS Foundation Trust ( Site 1902)Recruiting
Withington, Manchester, United Kingdom
Ipswich Hospital ( Site 1911)Recruiting
Ipswich, Suffolk, United Kingdom