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CDK4/6 Inhibitor
Pre-op Radiation + Abemaciclib + Letrozole for Breast Cancer
Phase 1
Recruiting
Led By Mridula A George, MD
Research Sponsored by Rutgers, The State University of New Jersey
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 from baseline, every six months, to five years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and feasibility of using a combination of radiation therapy and CDK4/6 inhibitors before surgery in patients with a certain type of breast cancer. The goal is to see
Who is the study for?
This trial is for individuals with HR+/HER2- breast cancer who can take oral meds, are surgery candidates (lumpectomy or mastectomy), have a tumor size of at least 1.5 cm, and meet specific hormone receptor criteria. They must not be suspected of having metastatic disease, should have an ECOG performance status ≤2, and certain blood levels must be within specified ranges.
What is being tested?
The RADIANT study tests the safety and potential benefits of combining pre-op radiation therapy with Abemaciclib and Letrozole in treating early-stage breast cancer. It's designed to see if this combo is tolerable and could inform future treatment effectiveness.
What are the potential side effects?
Potential side effects may include those common to radiation therapy such as skin changes or fatigue, as well as possible effects from Abemaciclib like diarrhea, low white blood cell counts leading to infection risk, liver issues indicated by altered blood tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline, every six months, to five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline, every six months, to five years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Secondary study objectives
Clinical efficacy of the study treatment regimen measured by Rates of Residual Cancer Burden (RCB).
Rate of breast-conserving surgery measured with with a 95% confidence interval for proportions
Rate of post-operative complications measured by descriptive statistics
+2 moreOther study objectives
Changes to DNA repair mechanism measured by Harvard/NSABP/Radiation Therapy Oncology Group (RTOG) breast Cosmesis scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combined Pre-Operative Therapy with Abemaciclib, Letrozole, and Radiation in HR+/HER2- Breast CancerExperimental Treatment2 Interventions
Part A:
* 28-day treatment cycle based on abemaciclib
* Abemaciclib 150mg BID (twice a day).
* Letrozole 2.5mg daily and Abemaciclib 150mg twice a day for three cycles prior to undergoing radiation therapy.
* On-treatment biopsy conducted between cycle 3, day 16, and cycle 4, day 1.
* This occurs two weeks prior to transitioning to Part B.
Dose Level 0 150mg Twice daily with at least 6 hours between doses Dose Level 1 100mg Twice daily with at least 6 hours between doses Dose Level 2 50mg Twice daily with at least 6 hours between doses
Part B:
* Continue treatment from Part A, 28-day cycle based on abemaciclib.
* Abemaciclib 150mg BID (twice a day) with letrozole 2.5mg daily.
* Part B focuses on the administration of radiation therapy following the three cycles of combined abemaciclib and letrozole.
* Targeted radiation treatment.
Part C:
* Two cycles of abemaciclib, 150mg twice a day.
* Letrozole 2.5mg daily.
Part D:
Surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890
Letrozole
2002
Completed Phase 4
~3150
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
455 Previous Clinical Trials
69,936 Total Patients Enrolled
14 Trials studying Breast Cancer
985 Patients Enrolled for Breast Cancer
Mridula George, MDLead Sponsor
2 Previous Clinical Trials
45 Total Patients Enrolled
Mridula A George, MDPrincipal InvestigatorCancer Institute of New Jersey Rutgers