Status:
ACTIVE_NOT_RECRUITING
Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
Lead Sponsor:
SOLTI Breast Cancer Research Group
Collaborating Sponsors:
Novartis
Alliance Foundation Trials, LLC.
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (...
Eligibility Criteria
Inclusion
- Main
- 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).
- Main
Exclusion
- Prior therapy with any CDK4/6 inhibitors.
- Patient has received prior treatment with chemotherapy for advanced/metastatic breast cancer
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT05207709
Start Date
March 28 2022
End Date
March 1 2027
Last Update
April 29 2025
Active Locations (71)
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1
Morton Plant Hospital
Clearwater, Florida, United States, 33756
2
University of Miami
Coral Gables, Florida, United States, 33124
3
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
4
Mount Sinai Florida
Miami, Florida, United States, 33140