RecruitingPhase 1NCT06139107

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer

Sponsor

Mridula George, MD

Enrollment

15 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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 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.

Eligibility

Sex: FEMALEMin Age: 60 Years

Inclusion Criteria12

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 Criteria17

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