Actively Recruiting
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
Led by Mridula George, MD · Updated on 2025-11-14
15
Participants Needed
4
Research Sites
423 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) 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.
CONDITIONS
Official Title
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed invasive breast cancer (ductal, lobular, or mixed histology) that is not palpable (cT1-T2N0) with minimum tumor size of 1.5 cm
- Expression of estrogen or progesterone receptors and negative HER2 expression according to ASCO/CAP guidelines
- Oncotype Breast Recurrence score less than 25 from core biopsy
- Post-menopausal status defined as either age 60 or older or younger than 60 with at least 12 months of amenorrhea without prior chemotherapy, tamoxifen, toremifene, ovarian suppression and with postmenopausal estradiol and FSH levels
- No clinical signs of metastatic disease
- ECOG performance status 0 to 2
- Eligible for surgery (lumpectomy or mastectomy) for local breast cancer treatment
- Able to swallow oral medications
- Adequate organ function including ANC >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin >8 g/dL, total bilirubin <1.5 x ULN, ALT and AST <3 x ULN
- HR positive/HER2 negative breast cancers allowed if no other exclusions apply
You will not qualify if you...
- History of breast cancer on the same side
- Prior treatment with CDK4/6 inhibitors or aromatase inhibitors
- History of radiation to chest wall or same side breast
- Inflammatory breast cancer
- Need for neoadjuvant chemotherapy
- Presence of distant metastatic disease
- Contraindication to surgery
- Uncontrolled hypertension (BP >190/100 mm Hg)
- Any condition or lab abnormality that places participant at unacceptable risk
- Life expectancy less than 12 weeks
- Allergy or hypersensitivity to study drugs
- Significant medical, laboratory, or psychiatric conditions
- Serious or uncontrolled preexisting medical conditions
- Major surgery within 14 days before enrollment
- Participation in another experimental treatment trial within 30 days or 5 half-lives
- Active systemic bacterial infection
- History of certain cardiac conditions such as syncope of cardiovascular origin, ventricular arrhythmia, or sudden cardiac arrest
AI-Screening
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Trial Site Locations
Total: 4 locations
1
RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, United States, 07109
Actively Recruiting
2
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
3
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
4
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08873
Actively Recruiting
Research Team
M
Mridula A George, MD
CONTACT
M
Mridula A George, MD
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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