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Aromatase Inhibitor
Ribociclib + Aromatase Inhibitor for Breast Cancer
Phase 2
Waitlist Available
Led By Mina Sedrak, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
Study Summary
This trial looks at the side effects and effectiveness of two drugs for treating hormone receptor positive breast cancer that has spread to other parts of the body.
Who is the study for?
This trial is for people aged 70 or older with hormone receptor positive, HER2-negative metastatic breast cancer. They must be able to swallow pills, have certain blood and organ function levels within normal ranges, and can't have had more than one chemotherapy treatment for metastatic disease. Those with severe medical conditions or recent major surgery aren't eligible.Check my eligibility
What is being tested?
The study is testing the effectiveness and side effects of ribociclib combined with an aromatase inhibitor in older patients. It aims to see if these drugs can stop cancer growth by blocking enzymes needed for cell growth. Participants will also undergo various tests like questionnaires and lab biomarker analysis.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver issues, heart rhythm changes (QT prolongation), high blood pressure, vomiting, diarrhea and other digestive system problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib
Secondary outcome measures
Clinical Benefit Rate as Determined by RECIST
Number of Participants With Dose Delays
Number of Participants With Dose Discontinuations
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ribociclib, aromatase inhibitor)Experimental Treatment5 Interventions
Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~2330
Aromatase Inhibitor
2012
Completed Phase 4
~910
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,665 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,458 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
Mina Sedrak, MDPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
99,382 Total Patients Enrolled
2 Trials studying Breast Cancer
740 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition where your central nervous system is involved, unless you meet all of the following criteria:You have a condition affecting your stomach or intestines that could make it hard for your body to absorb the study drugs. This could include diseases like ulcers, uncontrolled nausea, vomiting, or diarrhea.You have a Child-Pugh score of B or C.You have taken strong corticosteroid medication within two weeks of starting the study, or you have not fully recovered from the side effects of such treatment.Your platelet count is at least 100 billion per liter at the screening.It seems like there might be a missing context or incomplete information for this criterion. Can you please provide more details or clarify the criterion?You have already tried hormone therapy for advanced disease, but you can have had one round of chemotherapy.Your blood test results must be normal or can be corrected to normal with supplements before starting the study medication.You have been diagnosed with a specific type of breast cancer that is hormone receptor positive and HER2 negative, and it has spread to other parts of the body.You have serious heart problems that are not under control.Your hemoglobin level needs to be 9.0 grams per deciliter or higher when tested before the study.Your kidney function is good, with a creatinine level less than 1.5 mg/dL or a clearance rate of at least 50 mL/min.I'm sorry, but the criterion "Magnesium" is not clear enough for me to provide a simplified summary. Can you please provide more context or clarify the criterion?You are 70 years old or older.I'm not sure what you're asking. Could you please provide more context or clarify your question?Your liver enzymes (ALT and AST) should not be too high, unless you have liver metastases, in which case they can be a little higher.You need to have a standard heart test called an electrocardiogram (ECG) with specific results.Your heart's electrical activity, called QT interval, needs to be less than 450 milliseconds when measured at the screening.Your heart beats between 50 and 90 times per minute when you are at rest.The level of calcium in your blood, adjusted for the amount of albumin in your blood.You have been treated with a CDK4/6 inhibitor before.You are allergic to any of the ingredients in ribociclib.You had another type of cancer within the past 2 years that is still present or was not fully treated.You have another type of cancer that is not under control and requires treatment.Your bilirubin levels need to be within a certain range, unless you have a condition called Gilbert's syndrome.Your blood pressure is very high (over 160) or very low (under 90) when measured at the screening.Your white blood cell count is at least 1.5 billion per liter at the time of screening.I'm sorry, but I need more context or information to rewrite the criterion in a simpler language. Can you provide more details about the criterion related to potassium?
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ribociclib, aromatase inhibitor)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Does Ribociclib have a high potential for patient harm?
"While there is some evidence of Ribociclib's safety, it has not been proven effective yet and thus received a score of 2."
Answered by AI
In how many different medical centers is this research being conducted today?
"Currently, there are 9 active recruitment sites for this study. These include City of Hope Corona in Corona, City of Hope Mission Hills in Mission Hills, and City of Hope Rancho Cucamonga in Rancho Cucamonga. There are also 6 other locations."
Answered by AI
Are there any other investigations that have included Ribociclib?
"NIH Clinical Center first began studying ribociclib in 1996 and, to date, 946 clinical trials have completed. Out of these 105 trials are active with many taking place in Corona, New york."
Answered by AI
Are we currently enrolling patients in this study?
"This clinical trial is not recruiting at the moment. The listing was first posted on June 14th, 2018 and updated for the last time on May 16th, 2022. There are 2373 other trials involving receptors and progesterone currently enrolling patients as well as 105 Ribociclib trials with active participant searches."
Answered by AI
How many people have been recruited for this experiment?
"Unfortunately, this trial is no longer looking for patients that meet the criteria. The listing was first posted on 6/14/2018, with the most recent update being on 5/16/2022. However, there are 2373 and 105 other trials actively searching for patients right now who have receptors, progesterone and Ribociclib respectively."
Answered by AI
What are some popular applications for Ribociclib?
"While it is most commonly used as a treatment for advanced androgen dependent prostate cancer, ribociclib can also help patients who are experiencing no menstrual period in previous 6 months, hypoestrogenism, or vasomotor symptoms associated with menopause."
Answered by AI
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