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Hormone Therapy
Lerociclib + Hormone Therapy for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by EQRx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug, lerociclib, to see if it is safe and effective when used with standard endocrine therapy to treat HR+/HER2- MBC in both newly diagnosed and treatment-resistant patients. The trial population will consist of both men and women.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of AEs and SAEs
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lerociclib + letrozole or fulvestrantExperimental Treatment1 Intervention
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Who is running the clinical trial?
EQRx, Inc.Lead Sponsor
3 Previous Clinical Trials
57 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious lung condition or breathing problems.You have already been treated with chemotherapy or a CDK4/6 inhibitor, except for treatments before or after surgery.Your bone marrow and organs are working well.You have already been treated with fulvestrant before.You have a lot of disease in your organs that makes you unsuitable for endocrine therapy, according to the doctor in charge of the study.You have cancer that has spread to the lining of your abdomen.You have inflammatory breast cancer when you are screened.You have a brain tumor that is not getting worse and you are not taking certain medications for it.You have serious heart problems that are not under control.You have a history of a heart condition that causes abnormal heartbeats.You are taking estrogen pills or other estrogen treatments.You are taking certain medications that can affect how the study drug works in your body.You take medications that are mainly processed by the CYP3A4/5 enzyme and have a small range for safe and effective use.A heart test done in the past year showed that your heart is not pumping blood effectively, or you have a history of heart failure with reduced ejection fraction.You have a confirmed SARS-CoV-2 infection or a high fever at the time of screening.You have been diagnosed with estrogen-receptor positive and/or progesterone receptor positive breast cancer, and your cancer does not have the HER2 gene.You have breast cancer that has spread and cannot be cured with surgery or radiation.You are in good enough health to perform daily activities without any major problems.
Research Study Groups:
This trial has the following groups:- Group 1: Lerociclib + letrozole or fulvestrant
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.
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