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CDK4/6 Inhibitor
Abemaciclib + SRS for Breast Cancer Brain Metastases
Phase 1 & 2
Recruiting
Led By Kamran A Ahmed, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group performance status 0 to 2
Measurable brain disease per RANO-BM criteria that can be measured in at least one dimension as ≥ 0.5 cm for both intact brain metastases and post-operative cavities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will test if adding abemaciclib to endocrine therapy and SRS improves outcomes for patients with HR+/HER2- metastatic breast cancer brain metastases.
Who is the study for?
This trial is for individuals with HR+/HER2- metastatic breast cancer brain metastases. Participants can have had prior radiation treatments if there's measurable disease not previously treated with radiation. They must be able to undergo stereotactic radiosurgery, have ≤ 15 brain lesions eligible for this treatment, and a performance status of 0 to 2. Women must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The study tests the combination of abemaciclib and endocrine therapy alongside stereotactic radiosurgery (SRS) in patients with specific breast cancer that has spread to the brain. It's a single-arm study, meaning all participants receive the same treatment without comparison groups.See study design
What are the potential side effects?
Potential side effects include fatigue, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal blood tests, deep vein thrombosis or pulmonary embolism risks due to blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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I have a brain tumor or cavity from surgery that can be measured and is at least 0.5 cm big.
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I can provide a tissue sample from my tumor for testing.
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I am a candidate for targeted radiation to my brain or the area where my brain tumor was removed.
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I have 15 or fewer brain tumors suitable for targeted radiation.
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My breast cancer is hormone receptor positive.
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I can take pills by mouth.
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My breast cancer is not HER2 positive.
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My largest brain tumor is 4 cm or smaller.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intracranial Progression Free Survival (PFS)
Secondary outcome measures
Extracranial Progression Free Survival
Intracranial distant brain tumor control
Intracranial local brain tumor control
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2: Radiation Therapy and AbemaciclibExperimental Treatment3 Interventions
Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation at the phase 1 dose to sites of brain metastases or post-operative cavities with continued abemaciclib.
Group II: Phase 1: Radiation Therapy and AbemaciclibExperimental Treatment3 Interventions
Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation to sites of brain metastases or post-operative cavities with continued abemaciclib. In the phase I portion, safety will be monitored initially by a 3+3 design. If unexpected neurologic toxicities are noted, the dose of radiation therapy will be modified.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Endocrine therapy
2019
Completed Phase 3
~35460
Stereotactic Radiosurgery (SRS)
2012
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,461 Total Patients Enrolled
41 Trials studying Breast Cancer
5,780 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,617 Previous Clinical Trials
3,201,169 Total Patients Enrolled
64 Trials studying Breast Cancer
36,904 Patients Enrolled for Breast Cancer
Kamran A Ahmed, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I can take care of myself and am up and about more than half of my waking hours.If you can have babies, you need to have a negative pregnancy test within 7 days before starting the medicine abemaciclib.I haven't had any other cancer besides this one in the last 2 years.I have a brain tumor or cavity from surgery that can be measured and is at least 0.5 cm big.All side effects from my previous cancer treatments have mostly gone away.I have had fainting spells, irregular heartbeats, or sudden cardiac arrest due to heart issues.I am not allergic to any of the drugs or their components used in this study.I can provide a tissue sample from my tumor for testing.I agree to use birth control during and for 3 weeks after my treatment.I am a candidate for targeted radiation to my brain or the area where my brain tumor was removed.My organs are functioning well.I have 15 or fewer brain tumors suitable for targeted radiation.I do not have serious health issues that would stop me from joining this study.My breast cancer is hormone receptor positive.My cancer has spread to the lining of my brain and spinal cord.I have had SRS/FSRT but my current measurable cancer was not treated with radiation.I have received whole brain radiation therapy before.I have not taken abemaciclib for brain metastases or in the past 6 months for metastatic disease.I can take pills by mouth.I do not have any active infections.My breast cancer is not HER2 positive.I have not had major surgery or a significant injury in the last 14 days.My largest brain tumor is 4 cm or smaller.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Radiation Therapy and Abemaciclib
- Group 2: Phase 2: Radiation Therapy and Abemaciclib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What types of conditions has SRS been shown to effectively manage?
"Stereotactic Radiosurgery (SRS) is a commonly used treatment for high risk of recurrence and other conditions like advanced hr + her2 - breast cancer, endocrine therapy, and breast."
Answered by AI
How many patients are enrolled in this clinical trial?
"That is correct, the most recent information available on clinicaltrials.gov suggests that this research is still recruiting patients. The study was posted on November 30th, 2021 and updated on November 1st, 2022. They are currently seeking 31 individuals to take part in the trial at a single location."
Answered by AI
Are they looking for more test subjects at this time?
"Yes, this trial is currently looking for participants. The listing on clinicaltrials.gov shows that the first posting was on November 30th, 2021 and the last update was on November 1st, 2022."
Answered by AI
Does this research build on prior similar investigations?
"As of now, 97 ongoing clinical trials are testing the efficacy of Stereotactic Radiosurgery (SRS) in 1276 cities and 41 countries. The first such trial was sponsored by Eli Lilly and Company in 2009. That year, 220 patients completed Phase 1 drug approval for SRS. In the years since 2009, 35 more studies have been concluded."
Answered by AI
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