Belzutifan: Belzutifan 120 mg administered QD as an oral tablet.
Fulvestrant: Fulvestrant 500 mg administered as an IM injection.
Everolimus: Administered at 10mg via oral tablets QD.
Exemestane: Administered at 25 mg via oral tablets QD.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Progression-free Survival (PFS) — Up to approximately 29 months PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.
Trial sites (41)
Facility
City
Region
Status
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
Argentina
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
Bradfordhill ( Site 4100)
Santiago
Region M. de Santiago
IMAT S.A.S ( Site 1205)
Montería
Departamento de Córdoba
Oncologos Del Occidente ( Site 1200)
Pereira
Risaralda Department
Fundacion Valle del Lili ( Site 1204)
Cali
Valle del Cauca Department
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
Faculty of Medicine - Khon Kaen University ( Site 3502)
Muang
Changwat Khon Kaen
Songklanagarind Hospital ( Site 3501)
Hat Yai
Changwat Songkhla
The Royal Cornwall Hospital ( Site 1904)
Truro
England
St Bartholomews Hospital ( Site 1900)
London
London, City of
The Christie Hospital NHS Foundation Trust ( Site 1902)
Withington
Manchester
+ 1 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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