Actively Recruiting
A Phase IIA Trial Assessing the Tolerability of Abemaciclib with Endocrine Therapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer Who Have Progressed After Prior CDK 4/6 Inhibition
Led by City of Hope Medical Center · Updated on 2026-05-04
43
Participants Needed
6
Research Sites
N/A
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 research aims to evaluate the side effects of abemaciclib monotherapy in patients aged 70 years and older who have hormone receptor positive, HER2 negative metastatic breast cancer that has spread to other parts of the body. The study focuses on estimating the occurrence of severe toxicities (grade 3 or higher) and describing the full range of side effects, patient-reported adverse events, and treatment adherence. Researchers will also explore the relationship between geriatric assessment scores, aging biomarkers, and toxicity levels. Participants receive abemaciclib orally twice daily in 28-day cycles until disease progression or unacceptable side effects occur. After completing treatment, patients are followed up at 30 days and then every six months for two years. The study includes questionnaires assessing treatment impact and collects blood samples to measure drug concentrations. Throughout the trial, participants undergo regular evaluations including toxicity assessments, dose changes, hospitalizations, and survival outcomes. Researchers will monitor treatment adherence and patient quality of life using specific questionnaires. Follow-up visits continue for two years post-treatment to collect data on long-term effects, disease progression, and survival rates.
CONDITIONS
Brief Title
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent
- Age 70 years or older
- Life expectancy greater than 6 months
- Ability to read and understand English or Spanish
- Diagnosis of estrogen and/or progesterone receptor positive breast cancer confirmed by immunohistochemistry
- HER2-negative breast cancer confirmed as per ASCO/CAP guidelines
- Radiographically confirmed metastatic breast cancer
- Disease progression after prior endocrine therapy or treatment with palbociclib, ribociclib, or chemotherapy
- Recovery from acute side effects of prior chemotherapy to grade 1 or baseline, with at least 21 days washout after last chemotherapy dose
- Completion and recovery from radiotherapy with at least 14 days washout before randomization
- Absence of central nervous system involvement unless stable and meeting specific conditions
- No interstitial lung disease or pneumonitis
- Adequate blood counts: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 8 g/dL
- Liver enzyme levels within specified limits depending on liver metastases
- Total bilirubin within set limits depending on Gilbert's syndrome status
- Creatinine clearance ≥ 30 mL/min as measured by urine test or Cockcroft-Gault formula
You will not qualify if you...
- Major surgery within 14 days before starting study drug or not recovered from major side effects
- Use of prohibited medications including immune-suppressive agents and herbal medications during treatment phase
- Known hypersensitivity to abemaciclib components
- Active systemic bacterial, fungal, or viral infections requiring intravenous antibiotics or known active hepatitis B or C
- Gastrointestinal conditions affecting drug absorption such as ulcerative diseases or malabsorption syndrome
- History of severe heart rhythm problems or sudden cardiac arrest
- Other severe or uncontrolled medical conditions posing safety risks or affecting compliance
- Inability to swallow oral medications
- Serious uncontrolled preexisting conditions such as interstitial lung disease, severe dyspnea, severe renal impairment, or inflammatory bowel diseases
- History of non-compliance to medical treatments
- Prior malignancy within 2 years with current disease except certain treated skin or cervical cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive abemaciclib orally twice daily on days 1-28 of each 28-day cycle. Treatment continues in the absence of disease progression or unacceptable toxicity.
Visits occur every 28 days with each treatment cycle
Duration - Up to 2 years after treatment ends
Participants are followed up after treatment completion to monitor safety and survival outcomes.
1 visit at 30 days post treatment, then visits every 6 months for 2 years
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
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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