Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
Public ClinicalTrials.gov record NCT06428396. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06428396
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 26, 2024
- Primary completion
- May 4, 2027
- Completion
- Dec 24, 2028
- Last update posted
- Aug 27, 2026
2024 – 2028
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope - Phoenix ( Site 0006) | Goodyear | Arizona | 85338 | — |
| Cedars Sinai Medical Center ( Site 0012) | Beverly Hills | California | 90211 | — |
| Moores Cancer Center at UC San Diego Health ( Site 0025) | La Jolla | California | 92093 | — |
| USC/Norris Comprehensive Cancer Center ( Site 0013) | Los Angeles | California | 90033 | — |
| USC Norris Oncology Hematology Newport Beach ( Site 0029) | Newport Beach | California | 92663 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011) | Marietta | Georgia | 30060 | — |
| Southeastern Regional Medical Center ( Site 0010) | Newnan | Georgia | 30265 | — |
| CHRISTUS Highland ( Site 0005) | Shreveport | Louisiana | 71105 | — |
| Renown Regional Medical Center ( Site 0018) | Reno | Nevada | 89502 | — |
| MD Anderson Cancer Center at Cooper ( Site 0024) | Camden | New Jersey | 08103 | — |
| MD Anderson ( Site 0015) | Houston | Texas | 77030 | — |
| Mays Cancer Center ( Site 0022) | San Antonio | Texas | 78229 | — |
| SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034) | Madison | Wisconsin | 53715 | — |
| Medical College of Wisconsin - Froedtert Hospital ( Site 0014) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06428396, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06428396 live on ClinicalTrials.gov.