Actively Recruiting
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
Led by City of Hope Medical Center · Updated on 2026-05-04
43
Participants Needed
6
Research Sites
334 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
CONDITIONS
Official Title
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 70 years or older
- Life expectancy greater than 6 months
- Ability to read and understand English or Spanish
- Confirmed diagnosis of estrogen and/or progesterone receptor positive, HER2-negative breast cancer
- Radiographically confirmed metastatic breast cancer
- Disease progression after prior endocrine therapy, palbociclib, ribociclib, or chemotherapy
- Recovery from acute side effects of prior chemotherapy (except alopecia or grade 2 peripheral neuropathy) to grade 1 or baseline, with at least 21 days washout from last chemotherapy dose
- Recovery from acute effects of radiotherapy, with at least 14 days washout before randomization
- No central nervous system involvement or stable brain metastases meeting specified criteria
- No interstitial lung disease or pneumonitis
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 8 g/dL (transfusions allowed before treatment start)
- Liver function within specified limits depending on metastases
- Creatinine clearance ≥ 30 mL/min by urine test or Cockcroft-Gault formula
You will not qualify if you...
- Major surgery within 14 days before study drug or not fully recovered from surgery side effects
- Use of prohibited medications that cannot be stopped 7 days before starting study drug
- Known allergy to abemaciclib components
- Active systemic bacterial, fungal, or viral infections
- Gastrointestinal conditions affecting drug absorption
- History of serious heart rhythm problems or sudden cardiac arrest
- Severe or uncontrolled medical conditions posing safety risks
- Inability to swallow oral medications
- Serious preexisting conditions like interstitial lung disease or severe renal impairment
- History of non-compliance with medical treatments
- Prior malignancy within 2 years with active disease (except certain skin or cervical cancers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
3
City of Hope at Long Beach Elm
Long Beach, California, United States, 90813
Actively Recruiting
4
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Actively Recruiting
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
Actively Recruiting
Research Team
J
Joanne Mortimer, MD
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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