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CDK 4/6 Inhibitor
CDK 4/6 Inhibitor + Endocrine Therapy for Breast Cancer (LEADER Trial)
Phase 2
Recruiting
Led By Arielle Medford, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of prior CDK 4/6 inhibitor use
Participants must have biopsy proven localized ER+ (≥ 10%), HER2 negative, invasive breast cancer, with pathological stage (including post-neoadjuvant therapy) T1c-T4c, any N, M0, by AJCC 7th edition staging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
LEADER Trial Summary
This trial is testing whether the drug can help to treat ER-positive Breast Cancer.
Who is the study for?
This trial is for women at least 18 years old with ER-positive, HER2-negative breast cancer who've had surgery and been on endocrine therapy for 6+ months without major issues. They should be within 10 years of diagnosis and plan to continue therapy for another year. No prior CDK 4/6 inhibitors, recent chemo or radiotherapy, other cancers in the last 5 years, or severe health conditions.Check my eligibility
What is being tested?
The study tests Ribociclib combined with adjuvant endocrine therapy as a treatment option for ER-positive breast cancer. Participants will have taken endocrine therapy previously and are now adding Ribociclib to see if it improves outcomes.See study design
What are the potential side effects?
Ribociclib may cause side effects like low blood cell counts leading to infection risk, tiredness, nausea, hair loss, vomiting, diarrhea or constipation. It can also affect liver function and heart rhythm.
LEADER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never used CDK 4/6 inhibitors.
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My breast cancer is ER+ and HER2-, not spread beyond lymph nodes.
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I haven't had any cancer other than breast cancer in the last 5 years.
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I am fully active or can carry out light work.
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My breast cancer is mostly estrogen receptor positive and not HER2 positive.
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I am a woman, regardless of my menopause status.
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I have been on hormone therapy for breast cancer without major issues for at least 6 months.
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I am 18 years old or older.
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I have finished my main breast cancer surgery.
LEADER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ctDNA clearance
Secondary outcome measures
Comparison of Adverse Events
Disease-free survival (DFS)
Number of participants who have a switch in endocrine therapy
LEADER Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ribociclib + Endocrine RxExperimental Treatment2 Interventions
Ribociclib will be administered. Endocrine therapy will be administered.
Group II: Endocrine RxActive Control1 Intervention
Endocrine therapy will be administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,948 Previous Clinical Trials
13,207,119 Total Patients Enrolled
80 Trials studying Breast Cancer
132,778 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,614 Previous Clinical Trials
2,721,268 Total Patients Enrolled
56 Trials studying Breast Cancer
21,040 Patients Enrolled for Breast Cancer
Arielle Medford, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never used CDK 4/6 inhibitors.I haven't had any cancer other than breast cancer in the last 5 years.I am using effective birth control and will continue for 8 weeks after the study ends.I am fully active or can carry out light work.I was diagnosed with breast cancer within the last 10 years and will continue hormone therapy for at least another year.My cancer has spread to my brain or other parts of my body.I am a woman, regardless of my menopause status.I have been on hormone therapy for breast cancer without major issues for at least 6 months.My blood tests show my organs and bone marrow are working well.I am not taking drugs that affect CYP3A4 enzyme activity.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I do not have uncontrolled heart problems or abnormal heart rhythms.My breast cancer is ER+ and HER2-, not spread beyond lymph nodes.I haven't had chemotherapy or radiotherapy in the last 4 weeks, or I've recovered from their side effects.My breast cancer is mostly estrogen receptor positive and not HER2 positive.I finished any radiotherapy at least 30 days ago with minimal side effects.It's been over 30 days since my last chemotherapy or biological therapy, with minimal side effects.I am 18 years old or older.I have finished my main breast cancer surgery.Your blood contains detectable levels of ctDNA.I am HIV-positive and not on antiretroviral therapy.Your heart's electrical activity (measured by QTc) should be less than 470 milliseconds.
Research Study Groups:
This trial has the following groups:- Group 1: Ribociclib + Endocrine Rx
- Group 2: Endocrine Rx
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
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