RecruitingPhase 1NCT05996107

Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

A Phase 1B Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

30 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ribociclib (a targeted cancer drug that blocks cancer cell growth) given at the same time as radiation therapy after breast cancer surgery improves outcomes in patients with high-risk hormone receptor-positive, HER2-negative breast cancer. **You may be eligible if...** - You are 18 years or older - You have hormone receptor-positive (ER+ or PR+) and HER2-negative breast cancer - You have had surgery that removed all visible cancer with clear margins - You have more than 3 lymph nodes involved, OR 1–3 nodes with a large tumor (T3) or grade 3 cancer - You are scheduled for radiation therapy after surgery **You may NOT be eligible if...** - Your cancer is HER2-positive - Your cancer is hormone receptor-negative - You have not had surgery or still have residual cancer after surgery - Your cancer does not meet the high-risk criteria listed above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRibociclib

400 mg daily with a possibly dose reduction to 200 mg daily if required

RADIATIONPostoperative Radiation Therapy

50 Gy in 25 fractions or 42.56 Gy in 16 fraction +/- 10 Gy boost including comprehensive nodal


Locations(3)

University of Michigan

Ann Arbor, Michigan, United States

University of Michigan Health West

Wyoming, Michigan, United States

UHCMC Seidman Cancer Center

Cleveland, Ohio, United States

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NCT05996107


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