Study Comparing Ribociclib and Palbociclib for Advanced HER2-Enriched Breast Cancer

Sponsor: SOLTI Breast Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05207709

Provider View

This clinical trial is testing whether the drug ribociclib, combined with hormone therapy, is more effective than palbociclib with hormone therapy in extending the time without cancer progression in patients with advanced HER2-Enriched breast cancer.

Patient Parameters

Program Overview

The HARMONIA study is an international research project involving multiple centers. It aims to find out if ribociclib, when used with hormone therapy (letrozole or fulvestrant), is better than palbociclib with the same hormone therapy in delaying cancer progression in patients with advanced HR+/HER2- and HER2-Enriched breast cancer. The study plans to include about 456 patients from around the world. Additionally, the study will explore a smaller group of patients with a different type of breast cancer (Basal-like) to see how they respond to a different treatment (paclitaxel with or without Tislelizumab).

Eligibility Criteria

Inclusion Criteria

  • Have HR-positive and HER2-negative breast cancer confirmed by local tests.
  • Be in good general health with an ECOG performance status of 0 or 1.
  • Have advanced breast cancer that cannot be cured or has spread to other parts of the body.
  • Provide a tumor sample for analysis, taken during the metastatic period.
  • Have HER2-Enriched or Basal-like breast cancer as determined by specific tests.
  • Have measurable or non-measurable disease according to standard criteria.
  • Have good blood and organ function.
  • Be willing to attend scheduled visits and follow the treatment plan and procedures.
  • Women who can become pregnant must have a negative pregnancy test before starting the study and agree to use effective birth control methods.
  • Have a normal heart rhythm and rate as shown by an ECG test.

Exclusion Criteria

  • Have previously been treated with any CDK4/6 inhibitors.
  • Have received chemotherapy for advanced or metastatic breast cancer.

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