Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Main Inclusion Criteria:

Histologically documented HR-positive and HER2-negative breast cancer by local testing
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
Availability of FFPE tumor block for biomarker analysis, obtained during metastatic period.
HER2-E or Basal-like subtype as per central PAM50 analysis.
Measurable disease or non-measurable disease, as defined by RECIST v1.1
Adequate hematologic and end-organ function
Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
Women of childbearing potential must have confirmed negative serum pregnancy test within 7 days prior to randomization.
Women of CBP must be willing to use highly effective methods of contraception.

Patient must have a 6-lead or 12-lead ECG with ALL of the following parameters at screening:

QTcF interval (QT interval using Fridericia's correction) at screening < 450 msec.
Resting heart rate 50-90 beats per minute (determined from the ECG).

Main Exclusion Criteria:

Prior therapy with any CDK4/6 inhibitors.
Patient has received prior treatment with chemotherapy for advanced/metastatic breast cancer

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

456

Study ID:

NCT05207709

Recruitment Status:

Recruiting

Sponsor:

SOLTI Breast Cancer Research Group

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There are 50 Locations for this study

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Carle Cancer Center
Urbana Illinois, 61801, United States More Info
Maria Grosse-Perdekamp, MD
Contact
Sinai of Baltimore
Baltimore Maryland, 21215, United States More Info
Kalra Maitri, MD
Contact
Baptist Memorial Health Care
Oxford Mississippi, 38655, United States More Info
Ryan Yates, MD
Contact
NHOH
Londonderry New Hampshire, 03053, United States More Info
Douglas Weckstein, MD
Contact
Legacy Good Samaritan Hospital and Medical Cente
Portland Oregon, 97210, United States More Info
Mei Dong, MD
Contact
Bon Secours Memorial Regional Medical Center
Mechanicsville Virginia, 23113, United States More Info
Irvin William, MD
Contact
Unv. Wisconsin
Madison Wisconsin, 53792, United States More Info
Kair Wisinski, MD
Contact
Hospital Senhora da Oliveira - Guimarães
Creixomil , , Portugal More Info
Camila Coutinho, MD
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IPO Lisboa
Lisboa , 1500-, Portugal More Info
Antonio Moreira, MD
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Hospital Beatriz Ângelo
Loures , 2674-, Portugal More Info
João Godinho, Md
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Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE
Porto , 4200-, Portugal More Info
Susana Sousa, MD
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Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia , 4434-, Portugal More Info
Ana Joaquim, MD
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Institut Català d' Oncologia (ICO Badalona)
Badalona Barcelona, 08916, Spain More Info
Eduald Felip, MD
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Institut Català d'Oncologia (ICO Hospitalet)
Hospitalet de Llobregat Barcelona, 08908, Spain More Info
Sonia Pernas, MD
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Hospital General de Catalunya
Sant Cugat Del Vallès Barcelona, 08195, Spain More Info
Xavier Gonzalez, MD
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Hospital Son Llàtzer
Palma de Mallorca Illes Balears, 07198, Spain More Info
Maria Galán, MD
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Hospital Universitario de Canarias
Tenerife Islas Canarias, 38320, Spain More Info
Josefina Cruz Jurado, MD
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Hospital Clínico Universitario de A Coruña
A Coruña La Coruña, 15006, Spain More Info
Maria Eva Perez Lopez, MD
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Hospital Clínico Universitario de Santiago CHUS
Santiago De Compostela La Coruña, 15706, Spain More Info
Patricia Palacios, MD
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Hospital Universitario de Fuenlabrada
Fuenlabrada Madrid, 28942, Spain More Info
Diego Malón, MD
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Hospital Universitario Virgen de la Arrixaca
El Palmar Murcia, 30120, Spain More Info
Pilar Sánchez Henarejos, MD
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Hospital General Universitario de Alicante
Alicante , 03010, Spain More Info
José Juan Ponce Lorenzo, MD
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Hospital del Mar
Barcelona , 08003, Spain More Info
Tamara Martos, MD
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Vall d´Hebron University Hospital
Barcelona , 08035, Spain More Info
Esther Zamora, MD
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Hospital Clinic de Barcelona
Barcelona , 08036, Spain More Info
Olga Martinez, MD
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IOB-Institute of Oncology. Hospital Quironsalud Barcelona
Barcelona , 8023, Spain More Info
Fabricio Racca, MD
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Hospital de Basurto
Bilbao , 48013, Spain More Info
Purificación Martinez del Prado, MD
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Complejo Hospitalario San Pedro de Alcántara
Cáceres , 10003, Spain More Info
Maria Helena Lopez de Ceballos, MD
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Institut Català d' Oncologia de Girona (ICO Girona)
Girona , 17007, Spain More Info
Gemma Viñas, MD
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Hospital Universitario Virgen de las Nieves
Granada , 18014, Spain More Info
Veronica Conde Herrero, MD
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H. Clínico San Cecilio de Granada
Granada , 18016, Spain More Info
Isabel Blancas, MD
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Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas , 35010, Spain More Info
Ana Milena Vargas Prado, MD
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Complejo Asistencial Universitario de León
León , 24001, Spain More Info
Ana Lopez, MD
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Hospital Universitari Arnau de Vilanova de Lleida
Lleida , 25198, Spain More Info
Serafín Morales, MD
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Hospital Universitario La Princesa
Madrid , 28006, Spain More Info
Ana Isabel Ballesteros Garcia, MD
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Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain More Info
Elena Lopez Miranda, MD
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Fundación Jiménez Díaz
Madrid , 28040, Spain More Info
Yann Izarzugaza, MD
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Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
Eva Ciruelos, MD
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Hospital La Paz
Madrid , 28046, Spain More Info
Pilar Zamora, MD
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Centro Integral Oncológico Clara Campal (CIOCC)
Madrid , 28050, Spain More Info
Ana Luna, MD
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Hospital Universitario Puerta de Hierro de Majadahonda
Madrid , 28222, Spain More Info
Blanca Cantos, MD
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Hospital Virgen de la Victoria
Malaga , 29010, Spain More Info
Begoña Jimenez, MD
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Hospital Universitario Morales Meseguer
Murcia , 30008, Spain More Info
Francisco Ayala de la Peña, MD
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Hospital Sant Joan de Reus
Reus , 43204, Spain More Info
Kepa Amillano, MD
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Hospital Universitario de Salamanca
Salamanca , 37007, Spain More Info
César Rodriguez, MD
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Hospital Universitario Marqués de Valdecilla
Santander , 39008, Spain More Info
Carmen Hinojo González, MD
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Hospital Virgen de la Macarena
Sevilla , 41007, Spain More Info
Fernando Henao, MD
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Hospital Quiron Salud Sagrado Corazon Sevilla
Sevilla , 41013, Spain More Info
Juan Antonio Viruzuela, MD
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Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain More Info
Javier Salvador Bofil, MD
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Instituto Valenciano de Oncología (IVO)
Valencia , 46009, Spain More Info
Salvador Blanch, MD
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Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain More Info
Cristina Hernando Meliá, MD
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Hospital Clínico Universitario Lozano Blesa
Zaragoza , 50009, Spain More Info
Raquel Andrés, MD
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

456

Study ID:

NCT05207709

Recruitment Status:

Recruiting

Sponsor:


SOLTI Breast Cancer Research Group

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