Actively Recruiting
A Phase I Study of Concurrent Abemaciclib and Radiation Therapy for Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-28
28
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different doses of abemaciclib combined with hormone therapy and radiation therapy in people diagnosed with metastatic hormone receptor-positive (HR+), HER2-negative breast cancer. This Phase I study aims to find the maximum tolerated dose of abemaciclib when given alongside radiation therapy to bone metastases, helping to identify the best dose for future treatments. Participants will receive abemaciclib orally every 12 hours starting on the day of radiation therapy simulation through the end of radiotherapy, which lasts up to 28 days. Radiation therapy is given as either 27 Gy in 3 daily fractions or 30 Gy in 5 daily fractions, all completed within 28 days. After determining the maximum tolerated dose, additional patients needing bone metastases palliation will be enrolled for further evaluation. During the study, participants will undergo regular assessments to monitor tolerability and side effects over a period of up to one year. Researchers will track the maximum tolerated dose of abemaciclib and evaluate patient recovery from prior treatments. Participants must have adequate organ function and be able to swallow oral medications. Safety monitoring and adherence to treatment schedules will be part of the study procedures throughout the trial duration.
CONDITIONS
Brief Title
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at signing of informed consent
- Both male and female patients are allowed
- Histologically confirmed metastatic breast cancer, current stage IV
- Planned ablative radiotherapy (SBRT) to a bone metastasis
- Estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive tumor by immunohistochemistry (≥1% threshold)
- HER2 negative tumor status confirmed by immunohistochemistry or FISH
- Any prior treatments including hormonal therapy, chemotherapy, or prior abemaciclib, palbociclib, ribociclib
- Treating physician intends to resume abemaciclib after radiotherapy
- Recovery from chemotherapy acute effects (CTCAE Grade ≤1), with at least 21-day washout if no prior radiotherapy
- Recovery from prior radiotherapy acute effects with at least 14-day washout, no prior radiotherapy to current target site
- Ability to swallow oral medications
- Adequate organ function as defined in laboratory criteria
- May remain on hormonal therapy and abemaciclib before enrollment
- Discontinued other CDK4/6 inhibitors for at least 7 days and recovered from acute effects
- Measurable or non-measurable disease per RECIST v1.1
- ECOG status ≤2 or Karnofsky Performance Status ≥60
- Negative pregnancy test for premenopausal women and women less than 12 months post-menopause
- Women of childbearing potential agree to use highly effective contraception until 28 days after last investigational product dose
- Men agree to use barrier contraception during treatment and for 4 weeks after last investigational product dose
- Provide written informed consent
- Radiation to a metastatic bone lesion indicated, including spinal column lesions as per radiation oncologist
You will not qualify if you...
- Radiation treatment to bone lesions in the calvarium for dose-finding or expansion portions
- Current enrollment in another clinical trial with investigational product or incompatible medical research
- Receipt of experimental treatment within last 30 days or 5 half-lives prior to study start
- Radiation therapy within 14 days prior to starting investigational agents
- Serious or uncontrolled medical conditions that could preclude participation (e.g., interstitial lung disease, severe dyspnea, severe renal impairment, major GI surgery, Crohn's disease, ulcerative colitis, baseline Grade 2 or higher diarrhea)
- Pregnant or lactating females
- Active systemic bacterial, fungal, or viral infections (e.g., HIV, active hepatitis B or C)
- Personal history of syncope of cardiovascular origin, ventricular arrhythmia, or sudden cardiac arrest
- Significant chronic gastrointestinal disorders causing diarrhea
- Malignant spinal cord compression (ESCC2 or above)
- Prior radiation therapy to the current target site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 days
Participants receive Abemaciclib orally every 12 hours starting on the day of simulation through the final day of radiotherapy for up to 28 days. Radiation therapy is given as 27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed within 28 days of simulation via stereotactic body radiotherapy (SBRT).
Daily visits for radiation therapy over 3 or 5 days and ongoing medication dosing
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
L
Lior Braunstein, MD
R
Rui Wang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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