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NCT06428396 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Breast Cancer, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 2
Development phase
120
Enrollment target
20
Study locations

NCT06428396: Recruiting Phase 2 study of Metastatic Breast Cancer, sponsored by Merck Sharp & Dohme.

NCT06428396 is a Phase 2 study of Metastatic Breast Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 120 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06428396, a Phase 2 study of Metastatic Breast Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.

Conditions Studied

Metastatic Breast Cancer

Interventions

  • DRUG Belzutifan
  • DRUG Exemestane
  • DRUG Everolimus
  • DRUG Fulvestrant

Study Locations (20)

California

  • Cedars Sinai Medical Center ( Site 0012) - Beverly Hills
  • Moores Cancer Center at UC San Diego Health ( Site 0025) - La Jolla
  • USC/Norris Comprehensive Cancer Center ( Site 0013) - Los Angeles
  • USC Norris Oncology Hematology Newport Beach ( Site 0029) - Newport Beach

Buenos Aires

  • Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504) - CABA
  • Hospital Británico de Buenos Aires-Oncology ( Site 0500) - Ciudad Autónoma de Buenos Aires
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502) - Mar del Plata

Georgia

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011) - Marietta
  • Southeastern Regional Medical Center ( Site 0010) - Newnan

Texas

  • MD Anderson ( Site 0015) - Houston
  • Mays Cancer Center ( Site 0022) - San Antonio

Wisconsin

  • SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034) - Madison
  • Medical College of Wisconsin - Froedtert Hospital ( Site 0014) - Milwaukee

Arizona

  • City of Hope - Phoenix ( Site 0006) - Goodyear

Louisiana

  • CHRISTUS Highland ( Site 0005) - Shreveport

Nevada

  • Renown Regional Medical Center ( Site 0018) - Reno

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2024-11-27
Est. Completion 2028-10-07
Phase Phase 2
Merck Sharp & Dohme

558 total trials

What NCT06428396 shows while recruiting

NCT06428396 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (41% lower).

The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Belzutifan is the first listed.

NCT06428396 names 20 study sites across 12 states, led by California, Buenos Aires, Georgia.

Frequently Asked Questions

What is clinical trial NCT06428396 about?

NCT06428396 is a clinical study titled "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...

What is the current status of trial NCT06428396?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-11-27. Estimated completion is 2028-10-07.

What conditions does trial NCT06428396 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer.

What interventions are being tested in trial NCT06428396?

The interventions under investigation include: Belzutifan (DRUG), Exemestane (DRUG), Everolimus (DRUG), Fulvestrant (DRUG).

Who is sponsoring clinical trial NCT06428396?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06428396 being conducted?

This trial has 20 study locations across Arizona, California, Georgia, Louisiana, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06428396's enrollment target sits among peer trials

120 51st of 139 higher than 84 of 139 other Metastatic Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06428396

Source: ClinicalTrials.gov NCT06428396, the US trial registry maintained by the National Library of Medicine. NCT06428396 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.