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NCT05207709 · ClinicalTrials.gov registry record · Phase 3
Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
A Phase 3 study of Metastatic Breast Cancer, sponsored by SOLTI Breast Cancer Research Group.
- Active
- Registry status
- Phase 3
- Development phase
- 456
- Enrollment target
- 20
- Study locations
NCT05207709: Active Phase 3 study of Metastatic Breast Cancer, sponsored by SOLTI Breast Cancer Research Group.
NCT05207709 is a Phase 3 study of Metastatic Breast Cancer that is active but no longer recruiting, run by SOLTI Breast Cancer Research Group. The registered enrollment target is 456 participants, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05207709, a Phase 3 study of Metastatic Breast Cancer, is active but no longer recruiting, sponsored by SOLTI Breast Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 456 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
using RECIST 1.1 criteria, as assessed by local radiologists/investigators
Conditions Studied
Interventions
- DRUG Ribociclib + Letrozole OR Fulvestrant
- DRUG Palbociclib + Letrozole OR Fulvestrant
- DRUG Paclitaxel +/- Tislelizumab
Study Locations (20)
Florida
- Morton Plant Hospital - Clearwater
- University of Miami - Coral Gables
- Memorial Regional Hospital - Hollywood
- Mount Sinai Florida - Miami
Illinois
- Northwestern - Chicago
- Carle Cancer Center - Urbana
New York
- Nothwell Health - New York
- Montefiore - The Bronx
North Carolina
- University of North Carolina Lineberger - Chapel Hill
- Novant Health Care - Winston-Salem
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
- Dayton Clinical Oncology - Kettering
Kentucky
- University of Kentucky, Markey Cancer Center - Lexington
Maryland
- Sinai of Baltimore - Baltimore
Massachusetts
- Dana Faber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 3 |
What the registry record for NCT05207709 still lists
NCT05207709 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (126% higher).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Ribociclib + Letrozole OR Fulvestrant is the first listed.
NCT05207709 names 20 study sites across 13 states, led by Florida, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT05207709 about?
NCT05207709 is a clinical study titled "Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype". 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 fulvestran...
What is the current status of trial NCT05207709?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 456 participants. The study started on 2022-03-28. Estimated completion is 2027-03-01.
What conditions does trial NCT05207709 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT05207709?
The interventions under investigation include: Ribociclib + Letrozole OR Fulvestrant (DRUG), Palbociclib + Letrozole OR Fulvestrant (DRUG), Paclitaxel +/- Tislelizumab (DRUG).
Who is sponsoring clinical trial NCT05207709?
This trial is sponsored by SOLTI Breast Cancer Research Group, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05207709 being conducted?
This trial has 20 study locations across Florida, Illinois, Kentucky, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05207709's enrollment target sits among peer trials
456 14th of 139 higher than 126 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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