search
Back to results

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

Primary Purpose

Metastatic Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ribociclib + Letrozole OR Fulvestrant
Palbociclib + Letrozole OR Fulvestrant
Paclitaxel +/- Tislelizumab
Sponsored by
SOLTI Breast Cancer Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring PAM50, intrinsic subtype, HER2-Enriched

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carle Cancer CenterRecruiting
  • Sinai of Baltimore
  • Baptist Memorial Health Care
  • NHOHRecruiting
  • Legacy Good Samaritan Hospital and Medical Cente
  • Bon Secours Memorial Regional Medical CenterRecruiting
  • Unv. Wisconsin
  • Hospital Senhora da Oliveira - GuimarãesRecruiting
  • IPO Lisboa
  • Hospital Beatriz Ângelo
  • Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE
  • Centro Hospitalar Vila Nova de Gaia
  • Institut Català d' Oncologia (ICO Badalona)Recruiting
  • Institut Català d'Oncologia (ICO Hospitalet)Recruiting
  • Hospital General de CatalunyaRecruiting
  • Hospital Son LlàtzerRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital Clínico Universitario de A CoruñaRecruiting
  • Hospital Clínico Universitario de Santiago CHUSRecruiting
  • Hospital Universitario de FuenlabradaRecruiting
  • Hospital Universitario Virgen de la ArrixacaRecruiting
  • Hospital General Universitario de AlicanteRecruiting
  • Hospital del MarRecruiting
  • Vall d´Hebron University HospitalRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • IOB-Institute of Oncology. Hospital Quironsalud BarcelonaRecruiting
  • Hospital de BasurtoRecruiting
  • Complejo Hospitalario San Pedro de AlcántaraRecruiting
  • Institut Català d' Oncologia de Girona (ICO Girona)Recruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • H. Clínico San Cecilio de GranadaRecruiting
  • Hospital Universitario de Gran Canaria Doctor NegrinRecruiting
  • Complejo Asistencial Universitario de LeónRecruiting
  • Hospital Universitari Arnau de Vilanova de LleidaRecruiting
  • Hospital Universitario La PrincesaRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Fundación Jiménez DíazRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital La PazRecruiting
  • Centro Integral Oncológico Clara Campal (CIOCC)Recruiting
  • Hospital Universitario Puerta de Hierro de MajadahondaRecruiting
  • Hospital Virgen de la VictoriaRecruiting
  • Hospital Universitario Morales MeseguerRecruiting
  • Hospital Sant Joan de ReusRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting
  • Hospital Virgen de la MacarenaRecruiting
  • Hospital Quiron Salud Sagrado Corazon SevillaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Instituto Valenciano de Oncología (IVO)Recruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Hospital Clínico Universitario Lozano BlesaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ribociclib + Endocrine Therapy

Palbociclib + Endocrine Therapy

Paclitaxel +/- Tislelizumab - Exploratory cohort

Arm Description

Ribociclib + Fulvestrant or Letrozole

Palbociclib + Fulvestrant or Letrozole

Additional experimental Cohort that includes patients with Basal-Like intrinsic subtype.

Outcomes

Primary Outcome Measures

Progression-free survival
using RECIST 1.1 criteria, as assessed by local radiologists/investigators

Secondary Outcome Measures

Progression-free survival 2
defined as the time from randomization to first documented progression on next-line therapy or death, whichever occurs first
Overall Survival
the proportion of exitus patients
Overall response and clinical benefit
defined as percentage of patients with CR, PR per RECIST 1.1 or SD lasting 24 weeks or longer, as defined by RECIST 1.1.
Time to response and duration of response
defined per RECIST 1.1
Adverse events (safety)
Occurrence /severity of AEs, laboratory abnormalities, discontinuation rates, dose reductions/interruptions

Full Information

First Posted
January 4, 2022
Last Updated
June 21, 2023
Sponsor
SOLTI Breast Cancer Research Group
Collaborators
Novartis, Alliance Foundation Trials, LLC.
search

1. Study Identification

Unique Protocol Identification Number
NCT05207709
Brief Title
Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
Acronym
HARMONIA
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 Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOLTI Breast Cancer Research Group
Collaborators
Novartis, Alliance Foundation Trials, LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
PAM50, intrinsic subtype, HER2-Enriched

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ribociclib + Endocrine Therapy
Arm Type
Experimental
Arm Description
Ribociclib + Fulvestrant or Letrozole
Arm Title
Palbociclib + Endocrine Therapy
Arm Type
Experimental
Arm Description
Palbociclib + Fulvestrant or Letrozole
Arm Title
Paclitaxel +/- Tislelizumab - Exploratory cohort
Arm Type
Experimental
Arm Description
Additional experimental Cohort that includes patients with Basal-Like intrinsic subtype.
Intervention Type
Drug
Intervention Name(s)
Ribociclib + Letrozole OR Fulvestrant
Intervention Description
Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Palbociclib + Letrozole OR Fulvestrant
Intervention Description
Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Paclitaxel +/- Tislelizumab
Intervention Description
Patients in this arm could receive as the first line of therapy
Primary Outcome Measure Information:
Title
Progression-free survival
Description
using RECIST 1.1 criteria, as assessed by local radiologists/investigators
Time Frame
From date of randomization until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 62 months after the first patient enrolled
Secondary Outcome Measure Information:
Title
Progression-free survival 2
Description
defined as the time from randomization to first documented progression on next-line therapy or death, whichever occurs first
Time Frame
From randomization until documented progression to second line of therapy, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 62 months after the first patient enrolled
Title
Overall Survival
Description
the proportion of exitus patients
Time Frame
until patient death, assessed up to approximately 62 months after the first patient enrolled
Title
Overall response and clinical benefit
Description
defined as percentage of patients with CR, PR per RECIST 1.1 or SD lasting 24 weeks or longer, as defined by RECIST 1.1.
Time Frame
until disease progression or 24 weeks from treatment start.
Title
Time to response and duration of response
Description
defined per RECIST 1.1
Time Frame
time from treatment start to response and time from response to disease progression, assessed up to approximately 62 months after the first patient enrolled
Title
Adverse events (safety)
Description
Occurrence /severity of AEs, laboratory abnormalities, discontinuation rates, dose reductions/interruptions
Time Frame
from randomization/enrollment to end of study assessed up to approximately 62 months after the first patient enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan M Ferrero-Cafiero, PharmD
Phone
606819182
Email
juan.ferrero@gruposolti.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleix Prat, MD
Organizational Affiliation
Hospital Clínic of Barcelona / SOLTI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa A Carey, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan G Stover, MD
Organizational Affiliation
Stefanie Spielman Comprehensive Breast Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomás Pascual, MD
Organizational Affiliation
Hospital Clínic of Barcelona / SOLTI cancer research group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Grosse-Perdekamp, MD
Facility Name
Sinai of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalra Maitri, MD
Facility Name
Baptist Memorial Health Care
City
Oxford
State/Province
Mississippi
ZIP/Postal Code
38655
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Yates, MD
Facility Name
NHOH
City
Londonderry
State/Province
New Hampshire
ZIP/Postal Code
03053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Weckstein, MD
Facility Name
Legacy Good Samaritan Hospital and Medical Cente
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Dong, MD
Facility Name
Bon Secours Memorial Regional Medical Center
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
231136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irvin William, MD
Facility Name
Unv. Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kair Wisinski, MD
Facility Name
Hospital Senhora da Oliveira - Guimarães
City
Creixomil
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila Coutinho, MD
Facility Name
IPO Lisboa
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Moreira, MD
Facility Name
Hospital Beatriz Ângelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
João Godinho, Md
Facility Name
Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana Sousa, MD
Facility Name
Centro Hospitalar Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Joaquim, MD
Facility Name
Institut Català d' Oncologia (ICO Badalona)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduald Felip, MD
Facility Name
Institut Català d'Oncologia (ICO Hospitalet)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Pernas, MD
Facility Name
Hospital General de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Gonzalez, MD
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Galán, MD
Facility Name
Hospital Universitario de Canarias
City
Tenerife
State/Province
Islas Canarias
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefina Cruz Jurado, MD
Facility Name
Hospital Clínico Universitario de A Coruña
City
A Coruña
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Eva Perez Lopez, MD
Facility Name
Hospital Clínico Universitario de Santiago CHUS
City
Santiago De Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Palacios, MD
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Malón, MD
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Sánchez Henarejos, MD
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Juan Ponce Lorenzo, MD
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Martos, MD
Facility Name
Vall d´Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Zamora, MD
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Martinez, MD
Facility Name
IOB-Institute of Oncology. Hospital Quironsalud Barcelona
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabricio Racca, MD
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Purificación Martinez del Prado, MD
Facility Name
Complejo Hospitalario San Pedro de Alcántara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Helena Lopez de Ceballos, MD
Facility Name
Institut Català d' Oncologia de Girona (ICO Girona)
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma Viñas, MD
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Conde Herrero, MD
Facility Name
H. Clínico San Cecilio de Granada
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Blancas, MD
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrin
City
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Milena Vargas Prado, MD
Facility Name
Complejo Asistencial Universitario de León
City
León
ZIP/Postal Code
24001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Lopez, MD
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serafín Morales, MD
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Isabel Ballesteros Garcia, MD
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Lopez Miranda, MD
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann Izarzugaza, MD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Ciruelos, MD
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Zamora, MD
Facility Name
Centro Integral Oncológico Clara Campal (CIOCC)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Luna, MD
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanca Cantos, MD
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Begoña Jimenez, MD
Facility Name
Hospital Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Ayala de la Peña, MD
Facility Name
Hospital Sant Joan de Reus
City
Reus
ZIP/Postal Code
43204
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kepa Amillano, MD
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
César Rodriguez, MD
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Hinojo González, MD
Facility Name
Hospital Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Henao, MD
Facility Name
Hospital Quiron Salud Sagrado Corazon Sevilla
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Antonio Viruzuela, MD
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Salvador Bofil, MD
Facility Name
Instituto Valenciano de Oncología (IVO)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvador Blanch, MD
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Hernando Meliá, MD
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Andrés, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gruposolti.org/clinicaltrials/harmonia/?lang=en
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs