Abemaciclib for Metastatic Breast Cancer in Older Patients
This study is looking at the side effects of a drug called abemaciclib in older patients (age 70 and above) who have a type of breast cancer that has spread to other parts of the body (metastatic breast cancer). This cancer is hormone receptor positive and HER2 negative. Researchers want to see how many patients experience serious side effects (grade 3 or higher toxicities) from abemaciclib monotherapy. They will also look at other side effects, how often doses are changed, and how long patients live without their cancer getting worse. The study plans to enroll 43 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a phase IIa trial, which typically focuses on safety and effectiveness in a smaller group of people.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures side effects up to 30 days after treatment. Other endpoints, like survival, will be tracked over longer periods.
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NCT04305834
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
Recruiting
PHASE2Ages 70+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~43 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:AbemaciclibQuestionnaire Administration
At a glance
Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 3 or higher toxicities
Measured over Up to 30 days post treatment
Conditions
Where it's being run
6 sites across 3 statesCalifornia4
Massachusetts1
New York1
Study leadership
- Joanne Mortimer, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Documented informed consent of the participant
Age \>= 70 years
Life expectancy \> 6 months
Ability to read and understand English or Spanish
Measurable or non-measurable disease
Histologically or cytologically confirmed diagnosis of:
Estrogen-receptor positive and/or progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods according to the local institution standard protocol
HER2-negative breast cancer defined as negative if the IHC status is 0 or 1+, or if IHC is 2+ and in situ hybridization assay is negative per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Radiographically confirmed metastatic breast cancer
Progressed on prior endocrine therapy or palbociclib or ribociclib or chemotherapy
Patients who received chemotherapy recovered from the acute side effects to prior cancer therapy (except alopecia or residual grade 2 peripheral neuropathy) to =\< grade 1 or baseline. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy)
Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization
Absence of central nervous system (CNS) involvement unless they meet ONE of the following criteria:
Untreated brain metastases (e.g., lesions \< 1 cm) not needing immediate local therapy
Previously treated brain metastases not needing immediate local therapy
At least 4 weeks from the last date of prior therapy completion (including radiation and/or surgery) to starting the study treatment
Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases
Absence of interstitial lung disease/pneumonitis
Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L
Platelets \>= 100 x 10\^9/L
Hemoglobin \>= 8 g/dL
(Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion)
In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3.0 x upper limit of normal (ULN)
If the patient has liver metastases, ALT and AST \< 5 x ULN
In patients without Gilbert's syndrome, total bilirubin =\< 1.5 x ULN; In patients with Gilbert's syndrome, total bilirubin =\< 2.0 x ULN or direct bilirubin within normal limits (WLN)
Creatinine clearance of \>= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Exclusion
Major surgery within 14 days prior to receiving study drug or has not recovered from major side effect
Patient is currently receiving any of the prohibited medications detailed below and cannot be discontinued 7 days prior to starting study drug
Other investigational therapy should be given to participants
Anticancer agents other than the study medications administered as part of this study protocol should be given to participants. If such agents are required for a participant then the participant must first be withdrawn from the study
Co-medication that may interfere with study results; e.g. immune-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrolimus are prohibited during the treatment phase of the study, unless discussed with principal investigator felt to be of low clinical risk to the participant
Use of herbal medications may have unknown interactions with the metabolism of the study agents, and therefore are prohibited from use during the treatment phase of the trial
Known hypersensitivity to any of the excipients of abemaciclib
Active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive). Screening is not required for enrollment
Impairment of gastrointestinal (GI) function or GI disease that in the investigator's opinion may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
Patient has any other concurrent severe or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis)
Inability to swallow oral medications
Serious or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \< 30 ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)
History of non-compliance to medical regimen
Patients with a prior malignancy diagnosed within 2 years and with evidence of disease (except adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
What this trial measures
- Incidence of grade 3 or higher toxicitiesUp to 30 days post treatment
Adverse events will be characterized using the descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0.