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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

March 28, 2022

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2027

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Ribociclib + Letrozole OR Fulvestrant

Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks

DRUG

Palbociclib + Letrozole OR Fulvestrant

Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks

DRUG

Paclitaxel +/- Tislelizumab

Patients in this arm could receive as the first line of therapy

Trial Locations (71)

8023

IOB-Institute of Oncology. Hospital Quironsalud Barcelona, Barcelona

10003

Complejo Hospitalario San Pedro de Alcántara, Cáceres

10467

Montefiore, The Bronx

15006

Hospital Clínico Universitario de A Coruña, A Coruña

15706

Hospital Clínico Universitario de Santiago CHUS, Santiago de Compostela

17007

Institut Català d' Oncologia de Girona (ICO Girona), Girona

18014

Hospital Universitario Virgen de las Nieves, Granada

18016

H. Clínico San Cecilio de Granada, Granada

21215

Sinai of Baltimore, Baltimore

24001

Complejo Asistencial Universitario de León, León

25198

Hospital Universitari Arnau de Vilanova de Lleida, Lleida

25701

Edwards Comprehensive Cancer Center, Huntington

27103

Novant Health Care, Winston-Salem

27514

University of North Carolina Lineberger, Chapel Hill

28006

Hospital Universitario La Princesa, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Fundación Jiménez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital La Paz, Madrid

28050

Centro Integral Oncológico Clara Campal (CIOCC), Madrid

28222

Hospital Universitario Puerta de Hierro de Majadahonda, Madrid

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

29010

Hospital Virgen de la Victoria, Málaga

29302

Upstate Carolina Medical Center, Spartanburg

29425

The Medical University of South Carolina, Charleston

30008

Hospital Universitario Morales Meseguer, Murcia

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

33021

Memorial Regional Hospital, Hollywood

33124

University of Miami, Coral Gables

33140

Mount Sinai Florida, Miami

33756

Morton Plant Hospital, Clearwater

35010

Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas

37007

Hospital Universitario de Salamanca, Salamanca

38320

Hospital Universitario de Canarias, Santa Cruz de Tenerife

38655

Baptist Memorial Health Care, Oxford

39008

Hospital Universitario Marqués de Valdecilla, Santander

40536

University of Kentucky, Markey Cancer Center, Lexington

41007

Hospital Virgen de la Macarena, Seville

41013

Hospital Quiron Salud Sagrado Corazon Sevilla, Seville

Hospital Universitario Virgen del Rocio, Seville

43204

Hospital Sant Joan de Reus, Reus

43210

Ohio State University Comprehensive Cancer Center, Columbus

45429

Dayton Clinical Oncology, Kettering

46009

Instituto Valenciano de Oncología (IVO), Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

48013

Hospital de Basurto, Bilbao

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

53792

Unv. Wisconsin, Madison

60611

Northwestern, Chicago

61801

Carle Cancer Center, Urbana

68198

University of Nebraska Medical Center, Omaha

89121

Nevada Cancer Research Foundation, Las Vegas

97210

Legacy Good Samaritan Hospital and Medical Cente, Portland

97225

Providence Portland Medical Center, Portland

231136

Bon Secours Memorial Regional Medical Center, Mechanicsville

02215

Dana Faber Cancer Institute, Boston

03053

NHOH, Londonderry

11042-1069

Nothwell Health, New York

Unknown

Hospital Senhora da Oliveira - Guimarães, Creixomil

1500-650

IPO Lisboa, Lisbon

2674-514

Hospital Beatriz Ângelo, Loures

4200-072

Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE, Porto

4434-502

Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia

07198

Hospital Son Llàtzer, Palma de Mallorca

08916

Institut Català d' Oncologia (ICO Badalona), Badalona

08003

Hospital del Mar, Barcelona

08908

Institut Català d'Oncologia (ICO Hospitalet), L'Hospitalet de Llobregat

08195

Hospital General de Catalunya, Sant Cugat del Vallès

03010

Hospital General Universitario de Alicante, Alicante

08035

Vall d´Hebron University Hospital, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

Alliance Foundation Trials, LLC.

OTHER

lead

SOLTI Breast Cancer Research Group

OTHER

NCT05207709 - Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype | Biotech Hunter | Biotech Hunter