RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
Study sites (4)
NJ
- RWJBarnabas Health Clara Maas Medical Center · Belleville, NJ 07109Mridula George, MD · Study contact · 732-235-9809 · mridula@cinj.rutgers.eduKassie DiOrio · Study contact · 732-454-9795 · kassie.diorio@rutgers.eduMore trials in Belleville
- Cooperman Barnabas Medical Center · Livingston, NJ 07039Mridula George, MD · Study contact · 7322358909 · mridula@cinj.rutgers.eduKassie DiOrio · Study contact · 7324549795 · kassie.diorio@rutgers.eduMore trials in Livingston
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ 08903Mridula George, MD · Study contact · 7322358909 · mridula@cinj.rutgers.eduKassie DiOrio · Study contact · 7324549795 · kassie.diorio@rutgers.eduMore trials in New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset · Somerville, NJ 08873Mridula George, MD · Study contact · 732-235-8909 · mridula@cinj.rutgers.eduKassie DiOrio · Study contact · 7324549795 · kassie.diorio@rutgers.eduMore trials in Somerville