OncoMatch/Clinical Trials/NCT06678269
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
Is NCT06678269 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≥1% by IHC)
Documented estrogen receptor (ER) positive ... by immunohistochemistry. The threshold to qualify as ER ... positive is ≥1% per ASCO/CAP guidelines.
Required: PR (PGR) expression (≥1% by IHC)
Documented ... progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ... PgR positive is ≥1% per ASCO/CAP guidelines.
Required: HER2 (ERBB2) wild-type
HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO/CAP guidelines.
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiation therapy to current target site
No prior radiotherapy to the current intended target site is permitted (ie. reirradiation is excluded from this study). Prior radiation therapy to the current target site.
Lab requirements
Blood counts
ANC: ≥1.5 x 10^9/L; Platelets: ≥100 x 10^9/L; Hemoglobin: ≥8 g/dL (erythrocyte transfusions permitted)
Liver function
Total bilirubin: ≤1.5 x ULN (Gilbert's syndrome ≤2.0 x ULN and direct bilirubin within normal limits permitted); 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 →Frequently asked questions
Is NCT06678269 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy to current target site disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify