OncoMatch/Clinical Trials/NCT04305834
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
Is NCT04305834 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Abemaciclib for anatomic stage iv breast cancer ajcc v8.
Treatment: Abemaciclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 positive
Estrogen-receptor positive ... breast cancer determined by immunohistochemistry (IHC) methods
Required: PR (PGR) positive
progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods
Required: HER2 (ERBB2) wild-type (IHC 0 or 1+, or IHC 2+ and ISH negative)
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
Disease stage
Required: Stage IV (AJCC v8)
Metastatic disease required
Radiographically confirmed metastatic breast cancer
Prior therapy
Must have received: endocrine therapy
Progressed on prior endocrine therapy
Must have received: CDK4/6 inhibitor (palbociclib, ribociclib)
Progressed on prior ... palbociclib or ribociclib
Must have received: chemotherapy
Progressed on prior ... chemotherapy
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 8 g/dL (may receive erythrocyte transfusions)
Kidney function
Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or Cockcroft-Gault formula
Liver function
ALT and AST ≤ 3.0 x ULN (no liver mets); ALT and AST < 5 x ULN (with liver mets); total bilirubin ≤ 1.5 x ULN (no Gilbert's); total bilirubin ≤ 2.0 x ULN or direct bilirubin within normal limits (with Gilbert's syndrome)
Absolute neutrophil count (ANC) ≥ 1.5 X 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 8 g/dL ... ALT and AST ≤ 3.0 x ULN (no liver mets); ALT and AST < 5 x ULN (with liver mets); total bilirubin ≤ 1.5 x ULN (no Gilbert's); total bilirubin ≤ 2.0 x ULN or direct bilirubin within normal limits (with Gilbert's syndrome); Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- Dana Farber Cancer Institute · Boston, Massachusetts
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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