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Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
Sponsor: SOLTI Breast Cancer Research Group
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
456
Start Date
2022-03-28
Completion Date
2027-03-01
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
Ribociclib + Letrozole OR Fulvestrant
Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks
Palbociclib + Letrozole OR Fulvestrant
Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks
Paclitaxel +/- Tislelizumab
Patients in this arm could receive as the first line of therapy
Locations (71)
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
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
Unv. Wisconsin
Madison, Wisconsin, United States
Hospital Senhora da Oliveira - Guimarães
Creixomil, Portugal
IPO Lisboa
Lisbon, Portugal
Hospital Beatriz Ângelo
Loures, Portugal
Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE
Porto, Portugal
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, Portugal
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Institut Català d' Oncologia (ICO Badalona)
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
IOB-Institute of Oncology. Hospital Quironsalud Barcelona
Barcelona, Barcelona, Spain
Institut Català d'Oncologia (ICO Hospitalet)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Institut Català d' Oncologia de Girona (ICO Girona)
Girona, Girona, Spain
Hospital Clínico Universitario de A Coruña
A Coruña, La Coruña, Spain
Hospital Clínico Universitario de Santiago CHUS
Santiago de Compostela, La Coruña, Spain
Complejo Asistencial Universitario de León
León, León, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario Morales Meseguer
Murcia, Murcia, Spain
Hospital Quiron Salud Sagrado Corazon Sevilla
Seville, Sevilla, Spain
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Vall d´Hebron University Hospital
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Complejo Hospitalario San Pedro de Alcántara
Cáceres, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
H. Clínico San Cecilio de Granada
Granada, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Sant Joan de Reus
Reus, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Virgen de la Macarena
Seville, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain