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

NCT05207709 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2025-04-29

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Alliance Foundation Trials, LLC.

    collaborator OTHER

  • SOLTI Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Aleix Prat, MD · Hospital Clínic of Barcelona / SOLTI

  • Lisa A Carey, MD · UNC Lineberger Comprehensive Cancer Center

  • Dan G Stover, MD · Stefanie Spielman Comprehensive Breast Center

  • Tomás Pascual, MD · Hospital Clínic of Barcelona / SOLTI cancer research group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2026-03-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207709 on ClinicalTrials.gov