Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
Stopped early · Phase 3
Conditions studied: Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05207709
- Run by
- SOLTI Breast Cancer Research Group
- People needed
- 61
- Starts
- 2022-03-28
- Expected to finish
- 2026-03-26
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 — 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
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
- NHOH — Londonderry, New Hampshire, United States
- Nothwell Health — New York, New York, United States
- Montefiore — The Bronx, New York, United States
- University of North Carolina Lineberger — Chapel Hill, North Carolina, United States
- Novant Health Care — Winston-Salem, North Carolina, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- Dayton Clinical Oncology — Kettering, Ohio, United States
- Legacy Good Samaritan Hospital and Medical Cente — Portland, Oregon, United States
- Providence Portland Medical Center — Portland, Oregon, United States
- The Medical University of South Carolina — Charleston, South Carolina, United States
- Upstate Carolina Medical Center — Spartanburg, South Carolina, United States
- Edwards Comprehensive Cancer Center — Huntington, Virginia, United States
- Bon Secours Memorial Regional Medical Center — Mechanicsville, Virginia, United States
- Morton Plant Hospital — Clearwater, Florida, United States
Full record on ClinicalTrials.gov
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