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ACTIVE NOT RECRUITING Phase 3

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

NCT05207709 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Ribociclib + Letrozole OR Fulvestrant
  • DRUG Palbociclib + Letrozole OR Fulvestrant
  • DRUG Paclitaxel +/- Tislelizumab

Study Locations (20)

Florida

  • Morton Plant Hospital — Clearwater
  • University of Miami — Coral Gables
  • Memorial Regional Hospital — Hollywood
  • Mount Sinai Florida — Miami

Illinois

  • Northwestern — Chicago
  • Carle Cancer Center — Urbana

New York

  • Nothwell Health — New York
  • Montefiore — The Bronx

North Carolina

  • University of North Carolina Lineberger — Chapel Hill
  • Novant Health Care — Winston-Salem

Ohio

  • Ohio State University Comprehensive Cancer Center — Columbus
  • Dayton Clinical Oncology — Kettering

Kentucky

  • University of Kentucky, Markey Cancer Center — Lexington

Maryland

  • Sinai of Baltimore — Baltimore

Massachusetts

  • Dana Faber Cancer Institute — Boston

Trial Details

FieldValue
Enrollment Target 456 participants
Start Date 2022-03-28
Est. Completion 2027-03-01
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05207709

The ClinicalTrials.gov registry entry for NCT05207709 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 456 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SOLTI Breast Cancer Research Group, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Ribociclib + Letrozole OR Fulvestrant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05207709 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05207709 about?

NCT05207709 is a clinical study titled "Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype". 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 fulvestran...

What is the current status of trial NCT05207709?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 456 participants. The study started on 2022-03-28. Estimated completion is 2027-03-01.

What conditions does trial NCT05207709 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05207709?

The interventions under investigation include: Ribociclib + Letrozole OR Fulvestrant (DRUG), Palbociclib + Letrozole OR Fulvestrant (DRUG), Paclitaxel +/- Tislelizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05207709?

This trial is sponsored by SOLTI Breast Cancer Research Group, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05207709 being conducted?

This trial has 20 study locations across Florida, Illinois, Kentucky, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial