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RECRUITING Phase 2

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

NCT06428396 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06428396

The ClinicalTrials.gov registry entry for NCT06428396 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06428396 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Buenos Aires, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06428396?

The interventions under investigation include: Belzutifan (DRUG), Exemestane (DRUG), Everolimus (DRUG), Fulvestrant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06428396?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial