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RECRUITING Phase 1

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

NCT06139107 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Letrozole
  • DRUG Abemaciclib

Study Locations (4)

New Jersey

  • RWJBarnabas Health Clara Maas Medical Center — Belleville
  • Cooperman Barnabas Medical Center — Livingston
  • Rutgers Cancer Institute of New Jersey — New Brunswick
  • RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset — Somerville

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-08-22
Est. Completion 2032-09-30
Phase Phase 1

Sponsor

Mridula George, MD

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06139107

The ClinicalTrials.gov registry entry for NCT06139107 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mridula George, MD, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Letrozole is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06139107 reports 4 study locations spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06139107 about?

NCT06139107 is a clinical study titled "RADIANT: Pre-op Radiation With Abemaciclib and Letrozole". 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 ...

What is the current status of trial NCT06139107?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-08-22. Estimated completion is 2032-09-30.

What conditions does trial NCT06139107 study?

This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06139107?

The interventions under investigation include: Letrozole (DRUG), Abemaciclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06139107?

This trial is sponsored by Mridula George, MD, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06139107 being conducted?

This trial has 4 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial