OncoMatch/Clinical Trials/NCT06678269
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
Is NCT06678269 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Abemaciclib for metastatic breast cancer.
Treatment: Abemaciclib — The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (≥1% by IHC per ASCO/CAP guidelines)
Documented estrogen receptor (ER) positive ... by immunohistochemistry. The threshold to qualify as ER ... positive is ≥1% per ASCO/CAP guidelines.
Required: PR (PGR) overexpression (≥1% by IHC per ASCO/CAP guidelines)
Documented ... progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ... PgR positive is ≥1% per ASCO/CAP guidelines.
Required: HER2 (ERBB2) negative (HER2 negative by IHC or FISH per ASCO/CAP guidelines)
HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO/CAP guidelines.
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG OR KARNOFSKY 0–2
Patients must have an Eastern Cooperative Oncology Group (ECOG) status of ≤2 or Karnofsky Performance Status (KPS) ≥60.
Lab requirements
Blood counts
ANC: ≥1.5 x 10^9/L; Platelets: ≥100 x 10^9/L; Hemoglobin: ≥8 g/dL (transfusions permitted)
Liver function
Total bilirubin: ≤1.5 x ULN (≤2.0 x ULN with Gilbert's syndrome and direct bilirubin within normal limits); ALT and AST: ≤3 x ULN
The patient must have adequate organ function per the following criteria (as defined in Table 2): Hematologic ANC: ≥1.5 x 10^9/L Platelets: ≥100 x 10^9/L Hemoglobin: ≥8 g/dL ... Hepatic Total bilirubin: ≤1.5 x ULN ... ALT and AST: ≤3 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (All protocol activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) · Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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