Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intri… (NCT05207709) | Clinical Trial Compass
TerminatedPhase 3
Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
Stopped: The study was prematurely halted because enrollment was significantly delayed compared with the original projections due to the evolving therapeutic landscape.
United States, Portugal, Spain61 participantsStarted 2022-03-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* 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 Criteria:
* Prior therapy with any CDK4/6 inhibitors.
* Patient has received prior treatment with chemotherapy for advanced/metastatic breast cancer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival
Timeframe: From date of randomization until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 62 months after the first patient enrolled