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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06428396
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    Belzutifan 120 mg administered QD as an oral tablet.
  • Fulvestrant — DRUG
    Fulvestrant 500 mg administered as an IM injection.
  • Everolimus — DRUG
    Administered at 10mg via oral tablets QD.
  • Exemestane — DRUG
    Administered at 25 mg via oral tablets QD.

Study Details

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.

Key Dates

Start date
Nov 27, 2024
Status verified
May 2026
Primary completion
May 5, 2027
Completion
Dec 25, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 29 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
City of Hope - Phoenix ( Site 0006)GoodyearArizona85338
Study Coordinator
623-207-3000
Cedars Sinai Medical Center ( Site 0012)Beverly HillsCalifornia90211
Study Coordinator
310-423-3277
Moores Cancer Center at UC San Diego Health ( Site 0025)La JollaCalifornia92093
Study Coordinator
858-822-5366
USC/Norris Comprehensive Cancer Center ( Site 0013)Los AngelesCalifornia90033-
USC Norris Oncology Hematology Newport Beach ( Site 0029)Newport BeachCalifornia92663
Study Coordinator
323-865-3000
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)MariettaGeorgia30060-
Southeastern Regional Medical Center ( Site 0010)NewnanGeorgia30265-
CHRISTUS Highland ( Site 0005)ShreveportLouisiana71105-
Renown Regional Medical Center ( Site 0018)RenoNevada89502
Study Coordinator
775-982-3890
MD Anderson Cancer Center at Cooper ( Site 0024)CamdenNew Jersey08103
Study Coordinator
856-342-2000
MD Anderson ( Site 0015)HoustonTexas77030
Study Coordinator
713-792-2848
Mays Cancer Center ( Site 0022)San AntonioTexas78229
Study Coordinator
210-450-1000
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034)MadisonWisconsin53715
Study Coordinator
608-410-2767
Medical College of Wisconsin - Froedtert Hospital ( Site 0014)MilwaukeeWisconsin53226
Study Coordinator
414-805-0791

Find similar trials in Goodyear, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
City of Hope - Phoenix· Goodyear, AZCedars Sinai Medical Center· Beverly Hills, CAMoores Cancer Center at UC San Diego Health· La Jolla, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Oncology Hematology Newport Beach· Newport Beach, CANorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital· Marietta, GA

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