AFT-58 Harmonia

Clinical Trial 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
Trial Status Open to Enrollment
Start Date 10/26/2023
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Breast cancer
Description 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.
Eligibility Criteria

Inclusion Criteria

  • Male/female patients who are at least 18 years of age on the day of signing informed consent.
  • Histologically documented HR-positive and HER2-negative breast cancer by local testing: ER and/or PgR positivity are defined as >1% of cells expressing HR via IHC analysis
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Prior radiation therapy for metastatic disease is permitted. Patients must have recovered from radiotherapy toxicities prior to inclusion.
  • In all cases, patients may start letrozole or fulvestrant ≤ 28 days for advanced disease prior to inclusion in this trial, this is not considered a prior line of therapy.
  • Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Notes Study Details | Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype |
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail