Actively Recruiting
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-12
28
Participants Needed
7
Research Sites
210 weeks
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
The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.
CONDITIONS
Official 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 informed consent
- Male or female patients
- Histologically confirmed metastatic breast cancer, stage IV
- Plan to receive ablative stereotactic body radiotherapy (SBRT) to a bone metastasis
- Estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive (≥1% positive cells)
- HER2 negative tumor status confirmed by immunohistochemistry or FISH
- Any prior hormonal therapy or chemotherapy allowed, including prior CDK4/6 inhibitors
- Treating physician intends to resume abemaciclib after radiotherapy
- Recovered from acute chemotherapy effects (CTCAE Grade ≤1), with at least 21 days washout since last chemotherapy dose if no radiotherapy received
- Recovered from acute radiotherapy effects, with at least 14 days washout since radiotherapy completion
- No prior radiotherapy to the current target bone site
- Able to swallow oral medications
- Adequate organ function per laboratory criteria (ANC ≥1.5 x10^9/L, platelets ≥100 x10^9/L, hemoglobin ≥8 g/dL, total bilirubin ≤1.5 x ULN, ALT and AST ≤3 x ULN)
- May remain on hormonal therapy and abemaciclib before enrollment
- Discontinued other CDK4/6 inhibitors for at least 7 days and recovered from acute toxicities (Grade ≤1)
- Measurable or non-measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) status ≤2 or Karnofsky Performance Status ≥60
- Negative pregnancy test for premenopausal women of reproductive potential and women less than 12 months post-menopause
- Women of childbearing potential and men agree to use effective contraception during and after study
- Provide written informed consent
- Radiation to metastatic bone lesion indicated by treating radiation oncologist, including spinal bone lesions
You will not qualify if you...
- Bone lesions in the calvarium
- Currently enrolled in a clinical trial involving investigational drugs or devices incompatible with this study
- Received experimental treatment within 30 days or 5 half-lives before study intervention
- Radiation therapy within 14 days prior to starting investigational agents
- Serious or uncontrolled preexisting medical conditions preventing participation (e.g., interstitial lung disease, severe dyspnea requiring oxygen, severe renal impairment, major gastrointestinal surgery, Crohn's disease, ulcerative colitis, baseline Grade 2 or higher diarrhea)
- Pregnant or lactating females
- Active systemic bacterial, fungal, or detectable viral infections (e.g., HIV, active hepatitis B or C)
- Personal history of syncope of cardiovascular origin, pathological ventricular arrhythmia, or sudden cardiac arrest
- Significant chronic gastrointestinal disorders with diarrhea as a major symptom
- 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
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
CONTACT
R
Rui Wang, MD, PhD
CONTACT
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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