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CDK4/6 Inhibitor
Ribociclib Pharmacogenomics for Breast Cancer (LEANORA Trial)
Phase 4
Waitlist Available
Led By Sandra Swain, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female ≥18 years old at the time of informed consent
Documented HER2-negative tumor based on local testing on most recent tumor biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 8-16 of cycle 1 and prior to cycle 2 (each cycle is 28 days)
Awards & highlights
LEANORA Trial Summary
This trial is looking at how well a drug works in people with different versions of a gene.
Who is the study for?
This trial is for women over 18 with advanced breast cancer that's HER2-negative and hormone receptor-positive. Participants must be able to swallow pills, have good organ function, and identify as either non-Hispanic White or African American/Black. They should not have severe medical conditions, untreated brain metastases, active hepatitis or HIV, or be on other anti-cancer therapies besides the study protocol.Check my eligibility
What is being tested?
The study tests how different genetic variations in liver enzymes affect the body's handling of Ribociclib in two racial groups. It aims to personalize dosage based on these genetic differences to optimize treatment effectiveness while minimizing side effects.See study design
What are the potential side effects?
Ribociclib can cause low blood cell counts leading to infection risk, tiredness, nausea, hair loss, vomiting, diarrhea, constipation and headache. Liver problems and heart rhythm changes are less common but serious risks.
LEANORA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Your recent tumor biopsy shows that you do not have HER2-positive cancer.
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You have a certain level of physical ability, ranging from very good to limited.
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You have advanced breast cancer that cannot be cured with treatment.
Select...
It's okay if you have brain tumors that are not causing symptoms and are not getting worse with treatment.
LEANORA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 8-16 of cycle 1 and prior to cycle 2 (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 8-16 of cycle 1 and prior to cycle 2 (each cycle is 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ribociclib area-under-the-curve (AUC)
Secondary outcome measures
Change in QTc interval
Laboratory abnormalities - Aspartate aminotransferase (AST)
Laboratory abnormalities - neutropenia
+6 moreLEANORA Trial Design
2Treatment groups
Active Control
Group I: African American/BlackActive Control1 Intervention
Subject who self identify as African American or Black with metastatic HR+/HER2- advanced breast cancer (estimate 3 participants who are CYP3A5 poor metabolizers and approximately 15 participants who are CYP3A5 intermediate or normal metabolizers)
Group II: Non-Hispanic WhiteActive Control1 Intervention
Subjects who self-identify as non-Hispanic White with metastatic HR+/HER2- advanced breast cancer (estimate 3 participants who are CYP3A5 poor metabolizers and approximately 15 participants who are CYP3A5 intermediate or normal metabolizers)
Find a Location
Who is running the clinical trial?
Medstar Health Research InstituteOTHER
189 Previous Clinical Trials
115,552 Total Patients Enrolled
6 Trials studying Breast Cancer
1,247 Patients Enrolled for Breast Cancer
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,481 Total Patients Enrolled
33 Trials studying Breast Cancer
13,064 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
69 Previous Clinical Trials
137,782 Total Patients Enrolled
41 Trials studying Breast Cancer
130,492 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious liver disease, like hepatitis or cirrhosis, or you drink a lot of alcohol.You have had a liver or bone marrow transplant from someone else.Your recent tumor biopsy shows that you do not have HER2-positive cancer.You are currently taking a medication called a CDK4/6 inhibitor such as ribociclib, abemaciclib, or palbociclib.Your blood and organs are working properly, as shown by specific tests.You have symptoms from or untreated spread of cancer to your brain or spinal cord.You have HIV that is not under control.You have a current, active infection of hepatitis B or hepatitis C.You have a type of cancer that is causing symptoms in your organs.You have a certain level of physical ability, ranging from very good to limited.You had radiation treatment less than 4 weeks ago and have not fully recovered from any side effects.You have serious heart problems that are not being managed well or you are at high risk of developing a heart condition called QT prolongation.You have advanced breast cancer that cannot be cured with treatment.It's okay if you have brain tumors that are not causing symptoms and are not getting worse with treatment.Your most recent tumor biopsy shows that it is sensitive to estrogen or progesterone.Each group of people from different races has a set number of patients with a specific CYP3A5 gene type, based on the planned number of participants.You are allergic to any of the ingredients in ribociclib or fulvestrant.You have another cancer at the same time as the one being studied, unless it is a certain type of skin cancer or has been successfully treated.Your baseline electrocardiogram must show standard values for a 12-lead electrocardiogram.
Research Study Groups:
This trial has the following groups:- Group 1: African American/Black
- Group 2: Non-Hispanic White
Awards:
This trial has 3 awards, including:- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Are there still available positions for participants in this scientific endeavor?
"Affirmative. Clinicaltrials.gov has data confirming that this research is actively recruiting patients, having initially been posted on May 20th 2021 and last updated February 15th 2022. The trial requires 36 participants from 4 different sites."
Answered by AI
Could you please elucidate the past medical explorations that have included African American/Black participants?
"Since 2012, there have been 30 concluded clinical trials associated with African American/Black individuals that were conducted at Azienda Ospedaliera Universitaria Federico II. Presently, 48 live studies are taking place; notably many of these projects originate from Baltimore, Maryland."
Answered by AI
Is this medical experiment groundbreaking in its scope?
"The evaluation of African American/Black has been ongoing since 2012, when Pfizer sponsored the first large-scale trial involving 189 participants. As a result, it achieved Phase 1 & 2 approval and presently 48 active clinical trials are underway in 445 cities throughout 48 countries."
Answered by AI
What is the scope of enrollment for this clinical trial?
"Affirmative. The clinical trial is currently recruiting, as per the information located on clincialtrials.gov; its initial posting date was May 20th 2021 and it has been updated most recently on February 15th 2022. At present, there are 36 patient openings spread out across 4 different medical facilities."
Answered by AI
Are there any health risks associated with African American/Black individuals?
"The safety of African American/Black patients has been established in previous clinical trials, therefore receiving a score of 3 on our scale."
Answered by AI
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