Actively Recruiting
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-24
120
Participants Needed
41
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with estrogen receptor-positive (ER+)/HER2-negative invasive breast cancer that is locally advanced and not removable by surgery or metastatic and not curable
- Documented disease progression during or after last endocrine therapy
- Provide additional tissue sample from the same source used for ER and HER2 testing
- Received endocrine therapy in the noncurative setting with either progression on 12+ months of ET plus CDK4/6 inhibitor or at least 2 lines of ET including CDK4/6 inhibitor discontinued due to intolerance
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization
- Recovered to Grade 1 or baseline from adverse events due to prior cancer therapies; hormone replacement therapy allowed for endocrine-related adverse events; participants with Grade 2 or less neuropathy eligible
- Hepatitis B surface antigen positive participants are eligible if they have had antiviral therapy for at least 4 weeks and have undetectable viral load before randomization
You will not qualify if you...
- Breast cancer that can be treated with curative intent
- Unable to receive endocrine therapies such as fulvestrant or exemestane
- Difficulty tolerating or swallowing oral medications; gastrointestinal issues impairing absorption such as severe nausea, vomiting, obstruction, motility disorder, malabsorption, or prior gastric bypass
- Advanced or metastatic symptomatic visceral disease at risk of life-threatening complications
- Active bleeding disorders or on oral anti-vitamin K therapy
- History or current pneumonitis/interstitial lung disease requiring steroids
- Known harmful or suspected harmful germline BRCA mutation with previous PARP inhibitor treatment
- Prior fulvestrant treatment in adjuvant, unresectable locally advanced, or metastatic setting
- Prior cytotoxic chemotherapy or PARP inhibitor in noncurative advanced/metastatic setting
- Prior non-CNS radiotherapy or corticosteroids for radiation toxicity within 14 days before study drug
- Currently taking strong CYP3A4 inhibitors or inducers that cannot be stopped during the study
- Received systemic anticancer or investigational therapy within 4 weeks before randomization
- Received live or live-attenuated vaccine within 30 days before study drug
- Active hepatitis B and hepatitis C infection
- Significant cardiac disease including unstable angina, recent heart attack within 6 months, or severe congestive heart failure
- Not recovered from major surgery or ongoing surgical complications
AI-Screening
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Trial Site Locations
Total: 41 locations
1
City of Hope - Phoenix ( Site 0006)
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
Cedars Sinai Medical Center ( Site 0012)
Beverly Hills, California, United States, 90211
Actively Recruiting
3
Moores Cancer Center at UC San Diego Health ( Site 0025)
La Jolla, California, United States, 92093
Actively Recruiting
4
USC/Norris Comprehensive Cancer Center ( Site 0013)
Los Angeles, California, United States, 90033
Active, Not Recruiting
5
USC Norris Oncology Hematology Newport Beach ( Site 0029)
Newport Beach, California, United States, 92663
Actively Recruiting
6
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)
Marietta, Georgia, United States, 30060
Completed
7
Southeastern Regional Medical Center ( Site 0010)
Newnan, Georgia, United States, 30265
Actively Recruiting
8
CHRISTUS Highland ( Site 0005)
Shreveport, Louisiana, United States, 71105
Completed
9
Renown Regional Medical Center ( Site 0018)
Reno, Nevada, United States, 89502
Actively Recruiting
10
MD Anderson Cancer Center at Cooper ( Site 0024)
Camden, New Jersey, United States, 08103
Actively Recruiting
11
MD Anderson ( Site 0015)
Houston, Texas, United States, 77030
Actively Recruiting
12
Mays Cancer Center ( Site 0022)
San Antonio, Texas, United States, 78229
Actively Recruiting
13
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034)
Madison, Wisconsin, United States, 53715
Actively Recruiting
14
Medical College of Wisconsin - Froedtert Hospital ( Site 0014)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
15
Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504)
CABA, Buenos Aires, Argentina, C1056ABI
Actively Recruiting
16
Hospital Británico de Buenos Aires-Oncology ( Site 0500)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
Actively Recruiting
17
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Actively Recruiting
18
Instituto Alexander Fleming-Alexander Fleming ( Site 0505)
Buenos Aires, Buenos Aires F.D., Argentina, C1426ANZ
Actively Recruiting
19
Sanatorio Allende - Cerro-Oncology ( Site 0506)
Córdoba, Córdoba Province, Argentina, 5000
Actively Recruiting
20
Instituto de Oncología de Rosario ( Site 0501)
Rosario, Santa Fe Province, Argentina, S2000KZE
Actively Recruiting
21
Hospital Italiano de Córdoba ( Site 0508)
Córdoba, Argentina, X5004BAL
Actively Recruiting
22
Jewish General Hospital ( Site 0400)
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
23
Centro de Investigación del Maule ( Site 4106)
Talca, Maule Region, Chile, 3460000
Actively Recruiting
24
FALP ( Site 4102)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
25
Pontificia Universidad Catolica de Chile ( Site 4108)
Santiago, Region M. de Santiago, Chile, 8330024
Actively Recruiting
26
Bradfordhill ( Site 4100)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
27
IMAT S.A.S ( Site 1205)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
28
Oncologos Del Occidente ( Site 1200)
Pereira, Risaralda Department, Colombia, 660001
Actively Recruiting
29
Fundacion Valle del Lili ( Site 1204)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
30
Seoul National University Hospital ( Site 3100)
Seoul, South Korea, 03080
Actively Recruiting
31
Samsung Medical Center ( Site 3101)
Seoul, South Korea, 06351
Actively Recruiting
32
National Cheng Kung University Hospital ( Site 3300)
Tainan, Taiwan, 704302
Actively Recruiting
33
National Taiwan University Hospital ( Site 3301)
Taipei, Taiwan, 10002
Actively Recruiting
34
National Taiwan University Cancer Center ( Site 3302)
Taipei, Taiwan, 106
Actively Recruiting
35
Faculty of Medicine Siriraj Hospital ( Site 3500)
Bangkoknoi, Bangkok, Thailand, 10700
Actively Recruiting
36
Faculty of Medicine - Khon Kaen University ( Site 3502)
Muang, Changwat Khon Kaen, Thailand, 40002
Actively Recruiting
37
Songklanagarind Hospital ( Site 3501)
Hat Yai, Changwat Songkhla, Thailand, 90110
Actively Recruiting
38
The Royal Cornwall Hospital ( Site 1904)
Truro, England, United Kingdom, TR1 3LJ
Actively Recruiting
39
St Bartholomews Hospital ( Site 1900)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
40
The Christie Hospital NHS Foundation Trust ( Site 1902)
Withington, Manchester, United Kingdom, M20 4BX
Actively Recruiting
41
Ipswich Hospital ( Site 1911)
Ipswich, Suffolk, United Kingdom, IP4 5PD
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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