HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 95 sites worldwide. In addition, the HARMONIA trial will include an exploratory cohort of patients with HR+/HER2- and Basal-like disease treated with paclitaxel +/- Tislelizumab. This cohort does not have a predefined sample size and the objective is only exploratory, given the suggested lack of efficacy of the combinations of hormone therapy and CDK4/6 inhibitors in this subgroup of patients. Enrolment into the basal-like cohort will stop once the HER2-E disease cohort is fully enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
456
Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks
Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks
Patients in this arm could receive as the first line of therapy
Morton Plant Hospital
Clearwater, Florida, United States
University of Miami
Coral Gables, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Mount Sinai Florida
Miami, Florida, United States
Northwestern
Chicago, Illinois, United States
Carle Cancer Center
Progression-free survival
using RECIST 1.1 criteria, as assessed by local radiologists/investigators
Time frame: From date of randomization until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 62 months after the first patient enrolled
Progression-free survival 2
defined as the time from randomization to first documented progression on next-line therapy or death, whichever occurs first
Time frame: From randomization until documented progression to second line of therapy, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 62 months after the first patient enrolled
Overall Survival
the proportion of exitus patients
Time frame: until patient death, assessed up to approximately 62 months after the first patient enrolled
Overall response and clinical benefit
defined as percentage of patients with CR, PR per RECIST 1.1 or SD lasting 24 weeks or longer, as defined by RECIST 1.1.
Time frame: until disease progression or 24 weeks from treatment start.
Time to response and duration of response
defined per RECIST 1.1
Time frame: time from treatment start to response and time from response to disease progression, assessed up to approximately 62 months after the first patient enrolled
Adverse events (safety)
Occurrence /severity of AEs, laboratory abnormalities, discontinuation rates, dose reductions/interruptions
Time frame: from randomization/enrollment to end of study assessed up to approximately 62 months after the first patient enrolled
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Urbana, Illinois, United States
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Sinai of Baltimore
Baltimore, Maryland, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
Baptist Memorial Health Care
Oxford, Mississippi, United States
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