Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06139107 · ClinicalTrials.gov registry record · Phase 1
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
A Phase 1 study of Breast Cancer, sponsored by Mridula George, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 4
- Study locations
NCT06139107: Recruiting Phase 1 study of Breast Cancer, sponsored by Mridula George, MD.
NCT06139107 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Mridula George, MD. The registered enrollment target is 15 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06139107, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Mridula George, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
The outcome measure aims to characterize the safety and toxicity profile of the study treatment by assessing the occurrence and severity of adverse events (AEs) as measured using the CTCAE v.5. The CTCAE v.5 utilizes a standardized grading scale to assess the severity of adverse events. The scale consists of grades ranging from 1 to 5, with each grade corresponding to a specific level of severity. The grades are: Grade 1 Mild Event is asymptomatic or mild, requiring minimal or no medical interv
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-08-22 |
| Est. Completion | 2032-09-30 |
| Phase | Phase 1 |
What NCT06139107 shows while recruiting
NCT06139107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
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.
NCT06139107 reports a single indexed study location in New Jersey.
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.
What interventions are being tested in trial NCT06139107?
The interventions under investigation include: Letrozole (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT06139107?
This trial is sponsored by Mridula George, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06139107's enrollment target sits among peer trials
15 1144th of 1224 higher than 72 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
VS-6766+Abema+Fulv in Met HR+/HER- BC
RECRUITING · Phase 1
-
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
RECRUITING · Phase 1
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI