Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06139107
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-11-14
Brief Title:
RADIANT Pre-op Radiation With Abemaciclib and Letrozole
Sponsor:
Mridula George MD
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
RADIANT Study Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 CDK46 inhibitors in participants with hormone receptor positiveHER2 negative HRHER2- 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
Detailed Description:
In this phase 1b study researchers will conduct a comprehensive investigation into the concurrent administration of pre-operative radiation therapy and CDK46 inhibitors in a carefully selected participant population diagnosed with hormone receptor positiveHER2 negative HRHER2- breast cancer The study aims to elucidate the safety and feasibility of this combination therapy Participants will undergo rigorous evaluation and monitoring to assess the potential synergistic effects and adverse reactions resulting from the simultaneous use of radiation and CDK46 inhibitors Detailed clinical assessments imaging studies and laboratory analyses will be performed to monitor treatment response and any associated side effects
The study hypothesizes that this combination therapy will be well-tolerated paving the way for further investigations into its efficacy By closely examining the outcomes and tolerability of this treatment approach researchers aim to contribute valuable data to the understanding of novel therapeutic strategies for HRHER2- breast cancer The detailed analysis of participant responses and safety profiles in this study will provide crucial insights for optimizing future clinical interventions and improving outcomes for individuals diagnosed with this specific breast cancer subtype
The study hypothesizes that this combination therapy will be well-tolerated paving the way for further investigations into its efficacy By closely examining the outcomes and tolerability of this treatment approach researchers aim to contribute valuable data to the understanding of novel therapeutic strategies for HRHER2- breast cancer The detailed analysis of participant responses and safety profiles in this study will provide crucial insights for optimizing future clinical interventions and improving outcomes for individuals diagnosed with this specific breast cancer subtype
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Pro2023001900 | OTHER | Rutgers The State University of New Jersey | None |