Status:
RECRUITING
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
Lead Sponsor:
Mridula George, MD
Conditions:
Breast Cancer
Eligibility:
FEMALE
60+ years
Phase:
PHASE1
Brief Summary
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 positi...
Detailed Description
In this phase 1b study, researchers will conduct a comprehensive investigation into the concurrent administration of pre-operative radiation therapy and CDK4/6 inhibitors in a carefully selected parti...
Eligibility Criteria
Inclusion
- 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
- Able to swallow oral medications
- Adequate organ function for all of the following:
- Absolute Neutrophil (ANC) \>1.5 x 10/L Platelets \>100 x 10/L Hemoglobin \>8 g/dL - May receive erythrocyte transfusions to achieve this level Total Bilirubin \<1.5 x Upper Limit of Normal (ULN) Alanine Aminotransferase (ATL) and Aspartate Aminotransferase (AST) \<3 x ULN
- HR positive/HER2 -negative breast cancers are allowed as long as no other exclusions exist
Exclusion
- 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)
- Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
- Life expectancy \< 12 weeks
- History of allergy or hypersensitivity to any of the study drugs
- Any significant medical condition, laboratory abnormality, or psychiatric illness
- Serious and/or uncontrolled preexisting medical condition
- Has had major surgery within 14 days prior to enrollment
- Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently enrolled in any other type of medical research
- Has active systemic bacterial infection
- Personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
Key Trial Info
Start Date :
August 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2032
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06139107
Start Date
August 22 2024
End Date
September 30 2032
Last Update
November 14 2025
Active Locations (4)
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1
RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, United States, 07109
2
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States, 07039
3
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
4
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08873