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CDK 4/6 Inhibitor + Endocrine Therapy for Breast Cancer (LEADER Trial)
LEADER Trial Summary
This trial is testing whether the drug can help to treat ER-positive Breast Cancer.
LEADER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLEADER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LEADER Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Ribociclib + Endocrine Rx
- Group 2: Endocrine Rx
- 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.
- 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
Is this experiment a pioneering endeavor?
"Presently, Ribociclib is the subject of 48 different clinical trials across 445 urban areas and 48 nations. Pfizer initially conducted a trial in 2012 involving 189 participants that completed Phase 1 & 2; since then, 32 studies have been concluded."
How many individuals are being monitored as part of this clinical investigation?
"Affirmative. Clinicaltrials.gov attests that this clinical investigation is presently recruiting participants after being posted on December 12th 2017 and revised lastly on October 25th 2021. For the trial to be successful, it requires 120 individuals from 3 distinct sites."
Is Ribociclib a safe and efficacious remedy for individuals?
"As Ribociclib is currently in Phase 2, the safety score our team assigned to it was a 2. This rating accounts for existing data that supports its security but not any evidence of efficacy."
Is there currently an opportunity to join this medical experiment?
"Affirmative. Per the information on clinicaltrials.gov, this medical study is actively recruiting patients; it was initially posted December 12th 2017 and most recently updated October 25th 2021. The trial requires approximately 120 volunteers from three separate sites to be enrolled."
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