Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
Public ClinicalTrials.gov record NCT05207709. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05207709
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Interventions
- Ribociclib + Letrozole OR Fulvestrant Drug
- Palbociclib + Letrozole OR Fulvestrant Drug
- Paclitaxel +/- Tislelizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2022
- Primary completion
- Mar 25, 2026
- Completion
- Mar 25, 2026
- Last update posted
- Jun 24, 2026
2022 – 2026
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| University of Miami | Coral Gables | Florida | 33124 | — |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Mount Sinai Florida | Miami | Florida | 33140 | — |
| Northwestern | Chicago | Illinois | 60611 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| University of Kentucky, Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Sinai of Baltimore | Baltimore | Maryland | 21215 | — |
| Dana Faber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Baptist Memorial Health Care | Oxford | Mississippi | 38655 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Nevada Cancer Research Foundation | Las Vegas | Nevada | 89121 | — |
| NHOH | Londonderry | New Hampshire | 03053 | — |
| Nothwell Health | New York | New York | 11042-1069 | — |
| Montefiore | The Bronx | New York | 10467 | — |
| University of North Carolina Lineberger | Chapel Hill | North Carolina | 27514 | — |
| Novant Health Care | Winston-Salem | North Carolina | 27103 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Dayton Clinical Oncology | Kettering | Ohio | 45429 | — |
| Legacy Good Samaritan Hospital and Medical Cente | Portland | Oregon | 97210 | — |
| Providence Portland Medical Center | Portland | Oregon | 97225 | — |
| The Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Upstate Carolina Medical Center | Spartanburg | South Carolina | 29302 | — |
| Edwards Comprehensive Cancer Center | Huntington | Virginia | 25701 | — |
| Bon Secours Memorial Regional Medical Center | Mechanicsville | Virginia | 231136 | — |
| Unv. Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05207709, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2026 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05207709 live on ClinicalTrials.gov.