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

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.

Trial Details

NCT ID
NCT06428396
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Belzutifan
  • Fulvestrant
  • Everolimus
  • Exemestane
Locations (sample)
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Beverly Hills, California, United States|34.07362,-118.40036
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Newport Beach, California, United States|33.61891,-117.92895

Key Eligibility Criteria

  • Has a diagnosis of estrogen receptor positive (ER+)/human epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is eithe…
  • 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 inhibi…

For full eligibility, visit ClinicalTrials.gov.

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