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CDK4/6 Inhibitor
Ribociclib vs. Palbociclib for Breast Cancer (HARMONIA Trial)
Phase 3
Recruiting
Led By Lisa A Carey, 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
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
HARMONIA 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.Check my eligibility
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.See study design
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.
HARMONIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is either HER2-E or Basal-like subtype.
Select...
I can carry out all my daily activities without help.
Select...
My breast cancer cannot be cured and has spread.
Select...
My breast cancer is HR-positive and HER2-negative.
HARMONIA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization/enrollment to end of study assessed up to approximately 62 months after the first patient enrolled
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Adverse events (safety)
Overall Survival
Overall response and clinical benefit
+2 moreHARMONIA 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
1,611 Previous Clinical Trials
2,720,579 Total Patients Enrolled
57 Trials studying Breast Cancer
21,188 Patients Enrolled for Breast Cancer
Alliance Foundation Trials, LLC.OTHER
23 Previous Clinical Trials
24,576 Total Patients Enrolled
2 Trials studying Breast Cancer
5,799 Patients Enrolled for Breast Cancer
SOLTI Breast Cancer Research GroupLead Sponsor
41 Previous Clinical Trials
7,189 Total Patients Enrolled
21 Trials studying Breast Cancer
2,307 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who could become pregnant need to have a negative pregnancy test within a week before starting the study.My breast cancer is either HER2-E or Basal-like subtype.I can carry out all my daily activities without help.Your heart's electrical activity (measured by ECG) should show a specific QTcF interval and a resting heart rate within certain ranges.I have been treated with CDK4/6 inhibitors before.I am willing to use effective birth control methods.My breast cancer cannot be cured and has spread.My breast cancer is HR-positive and HER2-negative.I have had chemotherapy for advanced breast cancer before.We need a tumor sample from a previous biopsy to study specific markers.You have a disease that can be measured by specific guidelines called RECIST v1.1.My blood and organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Paclitaxel +/- Tislelizumab - Exploratory cohort
- Group 2: Ribociclib + Endocrine Therapy
- Group 3: Palbociclib + Endocrine Therapy
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Paclitaxel +/- Tislelizumab - Exploratory cohort been permitted by the FDA?
"Paclitaxel +/- Tislelizumab - Exploratory cohort has been granted a score of 3 due to the clinical evidence demonstrating its efficacy and safety. This assessment is based on Phase 3 trials that have already been completed."
Answered by AI
How many individuals are being recruited to participate in this experiment?
"This trial calls for 456 qualified participants, who can enrol in the study at Carle Cancer Center of Urbana or Sinai of Baltimore in Mississippi."
Answered by AI
Are there plentiful sites in this state conducting the clinical trial?
"The Carle Cancer Center in Urbana, Maryland; the Sinai of Baltimore in Baltimore, Mississippi; and Baptist Memorial Health Care in Oxford, New hampshire are just a few locations participating in this clinical study. In total there are 52 other sites involved."
Answered by AI
Are additional participants still being accepted for this medical experiment?
"As confirmed by clinicaltrials.gov, this medical study is still recruiting patients. It was published on March 28th 2022 and last updated on June 21st 2023."
Answered by AI
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