Actively Recruiting
Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer
Led by University of Michigan Rogel Cancer Center · Updated on 2026-01-28
30
Participants Needed
3
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with ER and/or PR-positive (≥ 1% positivity), HER2-negative breast cancer
- More than 3 lymph nodes involved on sentinel or axillary lymph node biopsy OR 1-3 lymph nodes involved with T3 disease OR 1-3 lymph nodes involved with grade 3 breast cancer
- Age 18 years or older
- Completed surgery with total removal of local disease and negative margins
- At least 21 days have passed since breast cancer surgery
- Completed chemotherapy (neoadjuvant or adjuvant), with at least 21 days since last chemotherapy dose
- Recovery from acute chemotherapy and surgery side effects to grade 1 or less (except neuropathy and alopecia)
- Adequate bone marrow and organ function based on specified laboratory values
- QTcF interval ≤ 450 ms on screening EKG
- Resting heart rate between 50-90 bpm
- Ability to swallow Ribociclib
- ECOG Performance Status 0-1 (Karnofsky > 60%)
- Archival tumor tissue available from surgery
- Willingness and ability to sign informed consent
- Negative pregnancy test within 14 days before starting study if of childbearing potential
You will not qualify if you...
- Prior radiation therapy to chest wall or regional nodes
- Previous treatment with CDK4/6 inhibitors
- Pregnant or breastfeeding
- Presence of distant metastases beyond regional lymph nodes or breast cancer recurrence before study enrollment
- Significant uncontrolled heart disease or cardiac abnormalities, including recent myocardial infarction, cardiomyopathy, low ejection fraction, long QT syndrome, or arrhythmias
- Uncontrolled high blood pressure (systolic > 160 mmHg)
- Severe or uncontrolled medical conditions that pose safety risks or limit life expectancy to 5 years or less
- Concurrent invasive malignancy or prior invasive malignancy treated within 2 years (except certain skin and cervical cancers)
- Gastrointestinal conditions that affect absorption of oral medications
- Receiving other anti-cancer therapies or investigational agents during study therapy
- Use of medications or supplements that strongly affect CYP3A4/5 metabolism within 7 days before randomization
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
University of Michigan Health West
Wyoming, Michigan, United States, 49519
Actively Recruiting
3
UHCMC Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
C
Cancer AnswerLine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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