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CDK4/6 Inhibitor

Abemaciclib and Radiation Therapy for Breast Cancer

Phase 1
Recruiting
Led By Lior Braunstein, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed metastatic breast cancer (mBC), current stage IV
Plan for palliative radiotherapy to a bone metastasis
Must not have
Females who are pregnant or lactating
Significant chronic gastrointestinal disorder with diarrhea as a major symptom
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing different doses of abemaciclib to see which dose works best for participants who are also receiving hormone therapy and radiation therapy."

Who is the study for?
This trial is for individuals with metastatic breast cancer. Participants will be receiving hormone therapy and radiation alongside the study treatment.
What is being tested?
The study is testing various doses of a drug called Abemaciclib to determine the most effective dose when used with hormone therapy and radiation in treating metastatic breast cancer.
What are the potential side effects?
Possible side effects of Abemaciclib may include diarrhea, fatigue, low white blood cell counts (increasing infection risk), nausea, abdominal pain, and potential liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is confirmed to be at stage IV.
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I am scheduled for radiation therapy to treat bone cancer spread.
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I am mostly self-sufficient and can carry out daily activities.
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My cancer is positive for estrogen or progesterone receptors.
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My tumor is HER2 negative according to specific tests.
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I am 18 years old or older.
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I stopped taking CDK4/6 inhibitors like palbociclib or ribociclib 7 days ago and have recovered from their side effects.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have a long-term stomach problem that mainly causes diarrhea.
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My cancer has caused severe pressure on my spinal cord.
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I have bone lesions in my skull or spine.
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I have had radiation therapy on the cancer area before.
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I do not have serious health issues that would stop me from joining the study.
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I do not have any active infections.
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I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose/MTD of abemaciclib

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with HR+, HER2- metastatic breast cancerExperimental Treatment1 Intervention
Participants will have a diagnosis of HR+, HER2- metastatic breast cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,675 Previous Clinical Trials
3,463,955 Total Patients Enrolled
64 Trials studying Breast Cancer
36,700 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,973 Previous Clinical Trials
597,710 Total Patients Enrolled
206 Trials studying Breast Cancer
82,295 Patients Enrolled for Breast Cancer
Lior Braunstein, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
~19 spots leftby Nov 2028
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