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

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06428396
Protocol IDs
6482-029 (primary)
NCI-2025-00468
LITESPARK-029
MK-6482-029
Study Sponsor
Merck Sharp & Dohme LLC

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.

Eligibility

  1. Has a diagnosis of estrogen receptor positive (ER+)/human epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent
  2. Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET)
  3. Provides additional tissue from the same sample used to determine ER and HER2 status locally
  4. 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 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4/6 inhibitor where the CDK 4/6 inhibitor was discontinued due to intolerance
  5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
  6. Participants who have AEs due to previous anticancer therapies must have recovered to =Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have =Grade 2 neuropathy are eligible
  7. Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.