Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype (AFT-58)

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

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.

Accepting Participants

Breast Cancer

Learn More

To learn more, visit ClinicalTrials.Gov or contact Clinical Research at 864-560-6812.

Principal Investigator(s)

Steven Corso, MD

Sponsor(s)

SOLTI Breast Cancer Research Group,

Key Trial Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Histologically documented HR-positive and HER2-negative breast cancer by local testing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
- Availability of FFPE tumor block for biomarker analysis, obtained during metastatic period.
- HER2-E or Basal-like subtype as per central PAM50 analysis.
- Measurable disease or non-measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end-organ function
- Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
- Women of childbearing potential must have confirmed negative serum pregnancy test within 7 days prior to randomization.
- Women of CBP must be willing to use highly effective methods of contraception.
- Patient must have a 6-lead or 12-lead ECG with ALL of the following parameters at screening:
  - QTcF interval (QT interval using Fridericia's correction) at screening < 450 msec.
  - Resting heart rate 50-90 beats per minute (determined from the ECG).
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Prior therapy with any CDK4/6 inhibitors.
- Patient has received prior treatment with chemotherapy for advanced/metastatic breast cancer

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