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CDK4/6 Inhibitor

Abemaciclib for Breast Cancer

Phase 1
Waitlist Available
Led By Smitha Menon, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligibility Criteria for Part 1 (Enrollment Criteria for the Dose-Escalation Cohort)
Inclusion Criteria for Dose-escalation Phase
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new treatment for cancer that may be more effective than current treatments.

Eligible Conditions
  • Solid Tumors
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities during dose-escalation phase.
Dose-limiting toxicities in dose-expansion phase.
Secondary outcome measures
Overall response rate.
Progression-free survival.

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%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Dry skin
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
7%
Flatulence
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%
Sepsis
1%
Pneumonitis
1%
Gastroenteritis viral
1%
Fall
1%
Hip fracture
1%
Lung infection
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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Abemaciclib and HCQ 600 mg b.i.d.Experimental Treatment2 Interventions
HCQ will have a dose escalation of a 3 + 3 design.
Group II: Abemaciclib and HCQ 400 mg b.i.d.Experimental Treatment2 Interventions
HCQ will have a dose escalation of a 3 + 3 design.
Group III: Abemaciclib and HCQ 200 mg b.i.d.Experimental Treatment2 Interventions
HCQ will have a dose escalation of a 3 + 3 design.
Group IV: Abemaciclib + HCQ (Optimal Dose) + endocrine therapyExperimental Treatment7 Interventions
This group will be divided into two cohorts: eligible participants who are endocrine therapy naive. eligible participants who had one prior line of endocrine therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Fulvestrant
FDA approved
Anastrozole
FDA approved
Letrozole
FDA approved

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,501 Total Patients Enrolled
13 Trials studying Breast Cancer
409,243 Patients Enrolled for Breast Cancer
Smitha Menon, MDPrincipal InvestigatorMedical College of Wisconsin

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer
Smitha Menon 2021. "Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04316169.
~0 spots leftby Jan 2027
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