RecruitingPhase 2NCT06428396

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

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

120 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — belzutifan (a pill) and fulvestrant (a hormone-blocking injection) — in women with advanced or metastatic breast cancer that is driven by estrogen (ER+) but not by HER2. It targets people whose cancer has continued to grow despite previous hormone therapies. **You may be eligible if...** - You have ER-positive, HER2-negative breast cancer that has spread or cannot be surgically removed - Your cancer has progressed despite at least 12 months of hormone therapy combined with a CDK4/6 inhibitor, OR you tried at least 2 lines of hormone therapy and had to stop the CDK4/6 inhibitor due to side effects - Your cancer has been confirmed to be progressing on imaging - You are in generally good health (ECOG 0–1) - Any side effects from prior treatment have resolved to mild or baseline levels **You may NOT be eligible if...** - Your breast cancer is still curable with treatment - You cannot tolerate fulvestrant or exemestane - Your cancer has spread extensively to organs in a rapidly life-threatening way - You have a history of serious lung inflammation that required steroids - You have a known BRCA gene mutation and have already received PARP inhibitor treatment - You have previously received fulvestrant - You have had chemotherapy or PARP inhibitors for metastatic disease - You have significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelzutifan

Belzutifan 120 mg administered QD as an oral tablet.

DRUGFulvestrant

Fulvestrant 500 mg administered as an IM injection.

DRUGEverolimus

Administered at 10mg via oral tablets QD.

DRUGExemestane

Administered at 25 mg via oral tablets QD.

Locations(41)

City of Hope - Phoenix ( Site 0006)

Goodyear, Arizona, United States

Cedars Sinai Medical Center ( Site 0012)

Beverly Hills, California, United States

Moores Cancer Center at UC San Diego Health ( Site 0025)

La Jolla, California, United States

USC/Norris Comprehensive Cancer Center ( Site 0013)

Los Angeles, California, United States

USC Norris Oncology Hematology Newport Beach ( Site 0029)

Newport Beach, California, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)

Marietta, Georgia, United States

Southeastern Regional Medical Center ( Site 0010)

Newnan, Georgia, United States

CHRISTUS Highland ( Site 0005)

Shreveport, Louisiana, United States

Renown Regional Medical Center ( Site 0018)

Reno, Nevada, United States

MD Anderson Cancer Center at Cooper ( Site 0024)

Camden, New Jersey, United States

MD Anderson ( Site 0015)

Houston, Texas, United States

Mays Cancer Center ( Site 0022)

San Antonio, Texas, United States

SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0034)

Madison, Wisconsin, United States

Medical College of Wisconsin - Froedtert Hospital ( Site 0014)

Milwaukee, Wisconsin, United States

Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504)

CABA, Buenos Aires, Argentina

Hospital Británico de Buenos Aires-Oncology ( Site 0500)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502)

Mar del Plata, Buenos Aires, Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 0505)

Buenos Aires, Buenos Aires F.D., Argentina

Sanatorio Allende - Cerro-Oncology ( Site 0506)

Córdoba, Córdoba Province, Argentina

Instituto de Oncología de Rosario ( Site 0501)

Rosario, Santa Fe Province, Argentina

Hospital Italiano de Córdoba ( Site 0508)

Córdoba, Argentina

Jewish General Hospital ( Site 0400)

Montreal, Quebec, Canada

Centro de Investigación del Maule ( Site 4106)

Talca, Maule Region, Chile

FALP ( Site 4102)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 4108)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 4100)

Santiago, Region M. de Santiago, Chile

IMAT S.A.S ( Site 1205)

Montería, Departamento de Córdoba, Colombia

Oncologos Del Occidente ( Site 1200)

Pereira, Risaralda Department, Colombia

Fundacion Valle del Lili ( Site 1204)

Cali, Valle del Cauca Department, Colombia

Seoul National University Hospital ( Site 3100)

Seoul, South Korea

Samsung Medical Center ( Site 3101)

Seoul, South Korea

National Cheng Kung University Hospital ( Site 3300)

Tainan, Taiwan

National Taiwan University Hospital ( Site 3301)

Taipei, Taiwan

National Taiwan University Cancer Center ( Site 3302)

Taipei, Taiwan

Faculty of Medicine Siriraj Hospital ( Site 3500)

Bangkoknoi, Bangkok, Thailand

Faculty of Medicine - Khon Kaen University ( Site 3502)

Muang, Changwat Khon Kaen, Thailand

Songklanagarind Hospital ( Site 3501)

Hat Yai, Changwat Songkhla, Thailand

The Royal Cornwall Hospital ( Site 1904)

Truro, England, United Kingdom

St Bartholomews Hospital ( Site 1900)

London, London, City of, United Kingdom

The Christie Hospital NHS Foundation Trust ( Site 1902)

Withington, Manchester, United Kingdom

Ipswich Hospital ( Site 1911)

Ipswich, Suffolk, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06428396

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