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RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

NCT06139107 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-14

No results posted yet for this study

Summary

This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability. The hypothesis is that the combination therapy will be well-tolerated, providing valuable insights into its effectiveness for future clinical applications.

Conditions

Interventions

DRUG

Abemaciclib

150mg twice a day for 3 cycles prior to radiation.

DRUG

Letrozole

Letrozole 2.5mg daily

Sponsors & Collaborators

  • Mridula George, MD

    lead OTHER

Principal Investigators

  • Mridula A George, MD · Cancer Institute of New Jersey Rutgers

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2026-09-30
Completion
2032-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139107 on ClinicalTrials.gov