RADIANT: Pre-op Radiation With Abemaciclib and Letrozole for Breast Cancer

This study is looking at how safe and practical it is to combine pre-surgery radiation therapy with two medications, abemaciclib and letrozole, for women with a specific type of breast cancer. This is for breast cancer that is hormone receptor positive (meaning its growth is fueled by hormones like estrogen or progesterone) and HER2 negative (meaning it doesn't have too much of a protein called HER2). You might be able to join if you are a woman, at least 60 years old, and have this type of breast cancer with a tumor at least 1.5 cm big that can't be felt. The study will check for side effects over five years to see if this combination treatment is well-tolerated. The study plans to enroll 15 participants, but its current status is unclear.

Study design: This is a Phase 1b interventional study, meaning it's an early-stage study looking at safety and feasibility. It aims to enroll 15 participants.
What's involved: Participants will receive abemaciclib twice a day for 3 cycles prior to radiation, and letrozole daily. They will be monitored for adverse events.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for adverse events from baseline, every six months, to five years.

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RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Recruiting

PHASE1Ages 60+InterventionalTreatment

Mridula George, MD

~15 participants

Updated 2025-11-14 on ClinicalTrials.gov

What's tested:AbemaciclibLetrozole

At a glance

Recruiting sites

4 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Measured over From baseline, every six months, to five years

Conditions

Breast Cancer

Where it's being run

4 sites across 1 states

New Jersey4

Study leadership

Mridula A George, MD · PRINCIPAL_INVESTIGATOR · Cancer Institute of New Jersey Rutgers

Who to contact

Mridula A George, MD

[email protected]

732-235-9081

Email the study team

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Do you actually qualify for this trial?

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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:

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

What this trial measures

Safety and tolerability of the combination of abemaciclib and radiation as assessed by adverse events (AEs). Using Common Terminology Criteria for Adverse Events (CTCAE v5.0)From baseline, every six months, to five years
The outcome measure aims to characterize the safety and toxicity profile of the study treatment by assessing the occurrence and severity of adverse events (AEs) as measured using the CTCAE v.5. The CTCAE v.5 utilizes a standardized grading scale to assess the severity of adverse events. The scale consists of grades ranging from 1 to 5, with each grade corresponding to a specific level of severity. The grades are: Grade 1 Mild Event is asymptomatic or mild, requiring minimal or no medical intervention. Grade 2 Moderate Event minimal to moderate interference with daily activities, and some medical intervention. Grade 3 Severe Event causes significant interference with daily activities, and medical intervention or treatment is required. Grade 4 Life-threatening or disabling Event poses immediate risk to life or function, requiring urgent medical intervention or treatment. Grade 5 Death Event results in death related to the adverse event.

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