Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) (NCT06428396)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope - Phoenix ( Site 0006) — Goodyear, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (41 Sites)
Showing the first 25 of 41 sites.
- City of Hope - Phoenix ( Site 0006) — Goodyear, Arizona
- Cedars Sinai Medical Center ( Site 0012) — Beverly Hills, California
- Moores Cancer Center at UC San Diego Health ( Site 0025) — La Jolla, California
- USC/Norris Comprehensive Cancer Center ( Site 0013) — Los Angeles, California
- USC Norris Oncology Hematology Newport Beach ( Site 0029) — Newport Beach, California
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011) — Marietta, Georgia
- Southeastern Regional Medical Center ( Site 0010) — Newnan, Georgia
- CHRISTUS Highland ( Site 0005) — Shreveport, Louisiana
- Renown Regional Medical Center ( Site 0018) — Reno, Nevada
- MD Anderson Cancer Center at Cooper ( Site 0024) — Camden, New Jersey
- MD Anderson ( Site 0015) — Houston, Texas
- Mays Cancer Center ( Site 0022) — San Antonio, Texas
- SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034) — Madison, Wisconsin
- Medical College of Wisconsin - Froedtert Hospital ( Site 0014) — Milwaukee, Wisconsin
- Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504) — CABA, Buenos Aires
- Hospital Británico de Buenos Aires-Oncology ( Site 0500) — Ciudad Autónoma de Buenos Aires, Buenos Aires
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502) — Mar del Plata, Buenos Aires
- Instituto Alexander Fleming-Alexander Fleming ( Site 0505) — Buenos Aires, Buenos Aires F.D.
- Sanatorio Allende - Cerro-Oncology ( Site 0506) — Córdoba, Córdoba Province
- Instituto de Oncología de Rosario ( Site 0501) — Rosario, Santa Fe Province
- Hospital Italiano de Córdoba ( Site 0508) — Córdoba,
- Jewish General Hospital ( Site 0400) — Montreal, Quebec
- Centro de Investigación del Maule ( Site 4106) — Talca, Maule Region
- FALP ( Site 4102) — Santiago, Region M. de Santiago
- Pontificia Universidad Catolica de Chile ( Site 4108) — Santiago, Region M. de Santiago
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.