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Ribociclib + Radiation Therapy for Breast Cancer

Phase 1
Recruiting
Led By Erin Cobain, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate baseline hematologic, hepatic and renal function as indicated by specific laboratory values
ECOG Performance Status 0-1 (Karnofsky > 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up through 30 days after the last dose of study drug or radiotherapy
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a drug called Ribociclib when combined with radiation therapy to treat women with high-risk ER+ breast cancer.

Who is the study for?
This trial is for women over 18 with high-risk, ER+/HER2- breast cancer who've had surgery with clear margins and completed chemotherapy. They must have good organ function, not be pregnant or breastfeeding, and can't have distant metastases or a history of CDK4/6 inhibitors. Participants need to be able to take oral medication and sign consent.Check my eligibility
What is being tested?
The study tests the safety and appropriate dose of Ribociclib when taken alongside standard postoperative radiation therapy in patients with certain high-risk breast cancers. The treatment includes daily Ribociclib for up to six weeks concurrent with radiation therapy.See study design
What are the potential side effects?
Potential side effects include issues related to blood cell counts (like anemia), liver function changes, kidney problems, fatigue, nausea, hair loss except neuropathy (nerve damage), and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood, liver, and kidney tests are within normal ranges.
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I am fully active or can carry out light work.
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I have taken a pregnancy test in the last 14 days and it was negative.
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I can swallow pills.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up through 30 days after the last dose of study drug or radiotherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up through 30 days after the last dose of study drug or radiotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity (DLT) of ribociclib administered concurrently with adjuvant RT 1 month post last RT dose
Secondary outcome measures
Cumulative incidence of local failure (i.e. local recurrence events)
Disease free survival
Local failure-free survival
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RT + RibociclibExperimental Treatment2 Interventions
All patients will be treated with Ribociclib and standard of care radiation therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~2330

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,231 Total Patients Enrolled
32 Trials studying Breast Cancer
3,958 Patients Enrolled for Breast Cancer
Erin Cobain, MDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
Corey Speers, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Media Library

Postoperative Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05996107 — Phase 1
Breast Cancer Research Study Groups: RT + Ribociclib
Breast Cancer Clinical Trial 2023: Postoperative Radiation Therapy Highlights & Side Effects. Trial Name: NCT05996107 — Phase 1
Postoperative Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05996107 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to participate in this trial currently available?

"As per the information on clinicaltrials.gov, this particular trial has ceased recruitment for participants - it was first published on October 1st 2023 and its last update occurred in August 10th of that same year. However, there are currently 2698 other medical trials actively seeking volunteers."

Answered by AI

What implications does RT + Ribociclib have for patient safety?

"The safety of RT + Ribociclib was assessed at a score of 1, as this initial trial has limited data that suggest it is efficacious and safe."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, Node Positive, HR+/HER2- Breast Cancer
2024. "Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, Node Positive, HR+/HER2- Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05996107.
~20 spots leftby Mar 2026
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