RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Part of paid clinical trials in Belleville, New Jersey.

Sponsor
Mridula George, MD
Study ID
NCT06139107
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    150mg twice a day for 3 cycles prior to radiation.
  • Letrozole — DRUG
    Letrozole 2.5mg daily

Study Details

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.

Key Dates

Start date
Aug 22, 2024
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2032

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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) [ Time Frame: From baseline, every six months, to five years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
RWJBarnabas Health Clara Maas Medical CenterBellevilleNew Jersey07109
Mridula George, MD
[email protected]
732-235-9809
Kassie DiOrio
[email protected]
732-454-9795
Cooperman Barnabas Medical CenterLivingstonNew Jersey07039
Mridula George, MD
[email protected]
7322358909
Kassie DiOrio
[email protected]
7324549795
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Mridula George, MD
[email protected]
7322358909
Kassie DiOrio
[email protected]
7324549795
RWJBarnabas Health - Robert Wood Johnson University Hospital SomersetSomervilleNew Jersey08873
Mridula George, MD
[email protected]
732-235-8909
Kassie DiOrio
[email protected]
7324549795

Find similar trials in Belleville, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
RWJBarnabas Health Clara Maas Medical Center· Belleville, NJCooperman Barnabas Medical Center· Livingston, NJRutgers Cancer Institute of New Jersey· New Brunswick, NJRWJBarnabas Health - Robert Wood Johnson University Hospital Somerset· Somerville, NJ

Related Studies