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CDK4/6 Inhibitor
Abemaciclib for Older Patients with Breast Cancer
Phase 2
Recruiting
Led By Joanne Mortimer, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance of >= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Absence of central nervous system (CNS) involvement unless meeting specific criteria
Must not have
Current use of prohibited medications detailed in the protocol
Active systemic bacterial infection, fungal infection, or detectable viral infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at abemaciclib as a possible treatment for breast cancer in patients age 70 and older.
Who is the study for?
This trial is for patients aged 70 or older with hormone receptor positive, HER2 negative metastatic breast cancer who have progressed on prior treatments. They must have recovered from previous therapies' side effects and not have certain infections, severe medical conditions, or a history of non-compliance to medical regimens.
What is being tested?
The study tests the safety of abemaciclib monotherapy in elderly patients with advanced breast cancer. It's a phase IIa trial focusing on those who've had other treatments before. Participants will also complete questionnaires as part of the study.
What are the potential side effects?
Potential side effects include gastrointestinal issues affecting drug absorption, possible liver enzyme elevations, blood cell count changes (like low ANC and platelets), and risks associated with any preexisting lung conditions like pneumonitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are functioning well enough, as shown by a test.
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My brain and spinal cord are not affected by my cancer, or they meet certain conditions.
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My cancer has worsened despite previous treatments.
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I've recovered from major side effects of my last chemotherapy, with at least 3 weeks since my last dose.
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I am 70 years old or older.
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My breast cancer has spread and this was confirmed by imaging tests.
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My breast cancer is positive for estrogen and/or progesterone receptors.
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I do not have lung inflammation or scarring.
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My breast cancer is HER2-negative according to specific tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any medications that are not allowed in the study.
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I do not have any ongoing serious infections.
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I have a digestive issue that affects how I absorb medication.
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I do not have any severe health conditions that would make treatment unsafe for me.
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I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.
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I am not using herbal medications during the trial.
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I cannot swallow pills.
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I haven't had major surgery in the last 2 weeks or still recovering from one.
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I was diagnosed with another cancer within the last 2 years and it's still present.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of grade 3 or higher toxicities
Secondary study objectives
Adherence to abemaciclib
Dose holds
Dose reductions
+11 moreOther study objectives
Incidence of toxicities at least possibly attributable to agent
Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
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: Treatment (abemaciclib)Experimental Treatment2 Interventions
Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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?
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,562 Total Patients Enrolled
42 Trials studying Breast Cancer
4,877 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,537 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,132 Patients Enrolled for Breast Cancer
Joanne Mortimer, MDPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
753 Total Patients Enrolled
2 Trials studying Breast Cancer
621 Patients Enrolled for Breast Cancer
Mina S SedrakPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
252 Total Patients Enrolled
Mina SedrakPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
128 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that are not allowed in the study.I have a digestive issue that affects how I absorb medication.Your platelet count is at least 100 billion per liter.I do not have any ongoing serious infections.My cancer can be measured by tests or seen on scans.I can read and understand either English or Spanish.You are expected to live for at least 6 more months.My kidneys are functioning well enough, as shown by a test.Your bilirubin levels must be within a certain range, unless you have Gilbert's syndrome, in which case there is a different range for your direct bilirubin levels.I do not have any serious or uncontrolled health conditions.My brain and spinal cord are not affected by my cancer, or they meet certain conditions.I do not have any severe health conditions that would make treatment unsafe for me.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.My cancer has worsened despite previous treatments.I am not using herbal medications during the trial.I've recovered from major side effects of my last chemotherapy, with at least 3 weeks since my last dose.You are taking medication that could affect the study results.You are allergic to any of the ingredients in abemaciclib.I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.I cannot swallow pills.Your ANC (absolute neutrophil count) is equal to or greater than 1.5 X 10^9/L.Your hemoglobin level is at least 8 grams per deciliter.Your liver function tests should be within a certain range, unless you have cancer that has spread to the liver.I haven't had major surgery in the last 2 weeks or still recovering from one.I am 70 years old or older.My breast cancer has spread and this was confirmed by imaging tests.My breast cancer is positive for estrogen and/or progesterone receptors.I do not have lung inflammation or scarring.My breast cancer is HER2-negative according to specific tests.I was diagnosed with another cancer within the last 2 years and it's still present.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.