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NCT05996107 · ClinicalTrials.gov registry record · Phase 1
Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT05996107: Recruiting Phase 1 study of Breast Cancer, sponsored by University of Michigan Rogel Cancer Center.
NCT05996107 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05996107, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this research study is to determine the safety, tolerability and dose of Ribociclib when combined with adjuvant radiation in women with high-risk ER+ breast cancer. Once enrolled on study, patients will begin treatment with Ribociclib 400 mg daily at the same time as they initiate standard of care adjuvant radiation therapy- 50 Gy in 25 fractions or 42.56 Gy in 16 fractions +/- 10 Gy boost including comprehensive nodal. Paitents will continue treatment with Ribociclib for up to 6 weeks.
Primary Outcome
Safety evaluations will be based on the incidence, intensity, and type of adverse events, and clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results. Safety variables will be tabulated and presented for all patients in the study. Exposure to study drug and reasons for discontinuation of study treatment will be tabulated.
Conditions Studied
Interventions
- DRUG Ribociclib
- RADIATION Postoperative Radiation Therapy
Study Locations (3)
Michigan
- University of Michigan - Ann Arbor
- University of Michigan Health West - Wyoming
Ohio
- UHCMC Seidman Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-02-27 |
| Est. Completion | 2030-06 |
| Phase | Phase 1 |
What NCT05996107 shows while recruiting
NCT05996107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 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 Ribociclib is the first listed.
NCT05996107 reports a single indexed study location in Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT05996107 about?
NCT05996107 is a clinical study titled "Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer". The purpose of this research study is to determine the safety, tolerability and dose of Ribociclib when combined with adjuvant radiation in women with high-risk ER+ breast cancer. Once enrolled on study, patients will begin treatment with Ribociclib 400 mg daily at the same time as they initiate st...
What is the current status of trial NCT05996107?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-02-27. Estimated completion is 2030-06.
What conditions does trial NCT05996107 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05996107?
The interventions under investigation include: Ribociclib (DRUG), Postoperative Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT05996107?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05996107 being conducted?
This trial has 3 study locations across Michigan, Ohio. 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 NCT05996107's enrollment target sits among peer trials
30 955th of 1224 higher than 227 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.
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