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CDK4/6 Inhibitor

Combined Pre-Operative Therapy with Abemaciclib, Letrozole, and Radiation in HR+/HER2- Breast Cancer 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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline, every six months, to five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 more

Other outcome measures

Changes to DNA repair mechanism measured by Harvard/NSABP/Radiation Therapy Oncology Group (RTOG) breast Cosmesis scale

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

~1710

Letrozole

2002

Completed Phase 4

~3240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,217 Total Patients Enrolled

15 Trials studying Breast Cancer

1,895 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it presently possible for individuals to participate in this clinical trial?

"Indeed, information available on clinicaltrials.gov indicates that this trial is actively seeking participants. The initial posting date for the trial was June 21st, 2024, with the most recent update made on April 1st, 2024. This study aims to enroll a total of 15 patients at one designated site."

Answered by AI

What is the risk level associated with using a combination of Abemaciclib, Letrozole, and radiation therapy before surgery for individuals with HR-positive/HER2-negative breast cancer?

"Assigned a safety rating of 1, our team at Power gauges the safety of Combined Pre-Operative Therapy involving Abemaciclib, Letrozole, and Radiation for HR+/HER2- Breast cancer. This evaluation is due to its Phase 1 status which indicates a scarcity of data backing up both safety and effectiveness aspects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Mridula George, MD 2024. "RADIANT: Pre-op Radiation With Abemaciclib and Letrozole". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139107.