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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Belzutifan 120 mg administered QD as an oral tablet.
Fulvestrant 500 mg administered as an IM injection.
Administered at 10mg via oral tablets QD.
Progression-free Survival (PFS)
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.
Time frame: Up to approximately 29 months
Progression-free Survival (PFS) at 6 months
PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at 6 months using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 28 months.
Time frame: Up to approximately 29 months
Progression-free Survival (PFS) at 12 months
PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at 12 months using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 28 months.
Time frame: Up to approximately 29 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 29 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.
Time frame: Up to approximately 29 months
Clinical Benefit Rate (CBR)
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Administered at 25 mg via oral tablets QD.
City of Hope - Phoenix ( Site 0006)
Goodyear, Arizona, United States
RECRUITINGCedars Sinai Medical Center ( Site 0012)
Beverly Hills, California, United States
RECRUITINGMoores Cancer Center at UC San Diego Health ( Site 0025)
La Jolla, California, United States
RECRUITINGUSC/Norris Comprehensive Cancer Center ( Site 0013)
Los Angeles, California, United States
RECRUITINGUSC Norris Oncology Hematology Newport Beach ( Site 0029)
Newport Beach, California, United States
RECRUITINGNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)
Marietta, Georgia, United States
COMPLETEDSoutheastern Regional Medical Center ( Site 0010)
Newnan, Georgia, United States
RECRUITINGCHRISTUS Highland ( Site 0005)
Shreveport, Louisiana, United States
COMPLETEDRenown Regional Medical Center ( Site 0018)
Reno, Nevada, United States
RECRUITINGMD Anderson Cancer Center at Cooper ( Site 0024)
Camden, New Jersey, United States
RECRUITING...and 31 more locations
CBR is defined as the percentage of participants who have CR: Disappearance of all target lesions, PR: At least a 30% decrease in the sum of diameters of target lesions, or stable disease (SD: Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study) for ≥24 weeks per RECIST 1.1 as assessed by BICR.
Time frame: Up to approximately 29 months
Number of Participants Who Experience an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 46 months
Number of Participants Who Discontinue Study Treatment Due To an AE
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 46 months