ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype

ClinicalTrials.gov ID: NCT05207709

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.

ClinicalTrials.gov public records Last synced May 8, 2026, 8:09 AM EDT

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

Study identification

NCT ID
NCT05207709
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
SOLTI Breast Cancer Research Group
Other
Enrollment
456 participants

Conditions and interventions

Interventions

  • Paclitaxel +/- Tislelizumab Drug
  • Palbociclib + Letrozole OR Fulvestrant Drug
  • Ribociclib + Letrozole OR Fulvestrant 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
Feb 28, 2026
Completion
Feb 28, 2027
Last update posted
Apr 28, 2025

2022 – 2027

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 Apr 28, 2025 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05207709 live on ClinicalTrials.gov.

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