clinical trial · NCT06428396
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
Merck Sharp & Dohme LLC·phase2·recruiting·n = 120
Metastatic Breast CancerBelzutifanFulvestrantEverolimusExemestane
brief 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.
started
Nov 27, 2024
primary completion
May 5, 2027
completion
Dec 25, 2028
last updated
May 18, 2026
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol