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

Running, not enrolling · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT06428396

Run by

Merck Sharp & Dohme LLC

People needed

120

Starts

2024-11-27

Expected to finish

2028-12-25

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a diagnosis of estrogen receptor positive (ER+)/human epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent
• Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET)
• Provides additional tissue from the same sample used to determine ER and HER2 status locally
• Has received ET in the noncurative setting and has 1) Radiographic disease progression on 12 months or more of ET in combination with CDK4/6 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4/6 inhibitor where the CDK 4/6 inhibitor was discontinued due to intolerance
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
• Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization

You may not qualify if…

• Has Breast cancer amenable to treatment with curative intent
• Is unable to receive any of the endocrine therapies (ETs) (ie, fulvestrant or exemestane)
• Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications such as uncontrolled nausea or vomiting (ie, CTCAE =Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction, motility disorder, malabsorption syndrome, or prior gastric bypass
• Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
• Has active, bleeding diathesis, or on oral anti-vitamin K medication
• Has history of noninfectious pneumonitis/interstitial lung disease including radiation pneumonitis that required steroids or has current pneumonitis/interstitial lung disease
• Has a known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition either in the adjuvant or metastatic setting
• Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting
• Has received any line of cytotoxic chemotherapy or PARP inhibitor in the unresectable or noncurative advanced/metastatic setting
• Has received prior radiotherapy for non-central nervous system (CNS) disease or required corticosteroids for radiation-related toxicities including radiation pneumonitis, within 14 days of the first dose of study intervention
• Is currently receiving either a strong inhibitor or inducer of CYP3A4 that cannot be discontinued for the duration of the study
• Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Has concurrent active Hepatitis B and Hepatitis C virus infection
• Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or Class IV congestive heart failure
• Has not adequately recovered from major surgery or have ongoing surgical complications

Where it is running

• 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

Full record on ClinicalTrials.gov

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