NCT06428396

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-27
• Primary completion: 2027-05-05
• Completion: 2028-10-07
• First posted: 2024-05-24
• Last updated: 2026-03-24

Locations

41 sites across 9 countries: United States, Argentina, Canada, Chile, Colombia, South Korea, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study