RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
Eligible age
60+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Mridula George, MD
You may qualify if…
- ✓ Histologically and/or cytologically confirmed diagnosis of invasive (ductal, lobular or mixed histology), Clinically inapparent tumor that is not palpable. (cT1-T2N0)disease. Minimum tumor size of 1.5 cm
- ✓ Expression of ER or progesterone receptors (PR)and negative expression of HER2 per American Society of Clinical Oncology, (ASCO) Common Alerting Protocol (CAP) guidelines
- ✓ Oncotype diagnosis (DX) Breast Recurrence score of less than 25 on core biopsy specimen
- ✓ Post-menopausal status defined:
- ✓ age \<60 with amenorrhea for at least 12 months in the absence of prior chemotherapy, tamoxifen, toremifene, or ovarian suppression and estradiol and FSH (follicle stimulating hormone) in postmenopausal range.
- ✓ No clinical suspicion of metastasis disease
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status of follicle stimulating hormone (PFS) ≤2
- ✓ Eligible to undergo surgery, either lumpectomy or mastectomy for local treatment of the breast cancer
You may not qualify if…
- ✕ History of ipsilateral breast cancer
- ✕ Prior treatment with CDK4/6 inhibitors or aromatase inhibitors
- ✕ History of chest wall or ipsilateral breast radiation
- ✕ Inflammatory breast cancer
- ✕ Needs neoadjuvant chemotherapy
- ✕ Presence of distant metastatic disease
- ✕ Contraindication for surgery
- ✕ Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg)
Where it's recruiting
Belleville · Livingston · New Brunswick · Somerville
Source: ClinicalTrials.gov · NCT06139107 · last updated 2025-11-14