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CDK4/6 Inhibitor

Ribociclib vs. Palbociclib for Breast Cancer (HARMONIA Trial)

Phase 3
Recruiting
Led By Aleix Prat, MD
Research Sponsored by SOLTI Breast Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HER2-E or Basal-like subtype as per central PAM50 analysis
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Must not have
Prior therapy with any CDK4/6 inhibitors
Patient has received prior treatment with chemotherapy for advanced/metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare two treatments to find out which is better at prolonging progression-free survival in patients with advanced HER2-E and HR+/HER2- breast cancer.

Who is the study for?
This trial is for women with advanced HR+/HER2- breast cancer, specifically the HER2-E or Basal-like subtype. They must have a tumor block available for analysis, measurable disease by RECIST v1.1 standards, good blood and organ function, an ECOG status of 0 to 1, and be able to follow the trial procedures. Women who can become pregnant must use effective contraception and not have used CDK4/6 inhibitors or chemotherapy for advanced cancer before.
What is being tested?
The HARMONIA study is testing whether Ribociclib combined with endocrine therapy (Letrozole or Fulvestrant) works better than Palbociclib with the same endocrine therapy in extending progression-free survival in patients with advanced breast cancer within the HER2-E subtype. It's an open-label phase III trial enrolling about 456 patients worldwide.
What are the potential side effects?
Potential side effects include those common to cancer treatments such as fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal tests, hair loss from Paclitaxel and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is either HER2-E or Basal-like subtype.
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I can carry out all my daily activities without help.
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My breast cancer cannot be cured and has spread.
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My breast cancer is HR-positive and HER2-negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with CDK4/6 inhibitors before.
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I have had chemotherapy for advanced breast cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization/enrollment to end of study assessed up to approximately 62 months after the first patient enrolled
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization/enrollment to end of study assessed up to approximately 62 months after the first patient enrolled for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival
Secondary study objectives
Adverse events (safety)
Overall Survival
Overall response and clinical benefit
+2 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Ribociclib + Endocrine TherapyExperimental Treatment1 Intervention
Ribociclib + Fulvestrant or Letrozole
Group II: Palbociclib + Endocrine TherapyExperimental Treatment1 Intervention
Palbociclib + Fulvestrant or Letrozole
Group III: Paclitaxel +/- Tislelizumab - Exploratory cohortExperimental Treatment1 Intervention
Additional experimental Cohort that includes patients with Basal-Like intrinsic subtype.

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,137 Total Patients Enrolled
58 Trials studying Breast Cancer
21,300 Patients Enrolled for Breast Cancer
Alliance Foundation Trials, LLC.OTHER
23 Previous Clinical Trials
24,577 Total Patients Enrolled
2 Trials studying Breast Cancer
5,799 Patients Enrolled for Breast Cancer
SOLTI Breast Cancer Research GroupLead Sponsor
42 Previous Clinical Trials
7,467 Total Patients Enrolled
21 Trials studying Breast Cancer
2,307 Patients Enrolled for Breast Cancer

Media Library

Palbociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05207709 — Phase 3
Breast Cancer Research Study Groups: Paclitaxel +/- Tislelizumab - Exploratory cohort, Ribociclib + Endocrine Therapy, Palbociclib + Endocrine Therapy
Breast Cancer Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT05207709 — Phase 3
Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05207709 — Phase 3
~146 spots leftby Mar 2026
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