OncoMatch/Clinical Trials/NCT06341621
Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
Is NCT06341621 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including 3-year abemaciclib without chemo and treatment of physician's choice for breast cancer.
Treatment: 3-year abemaciclib without chemo · treatment of physician's choice — This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER≥50%) (ER≥50%)
ER≥50%
Required: HER2 (ERBB2) negative (IHC 0, 1+, or 2+ with negative ISH) (IHC 0, 1+, or 2+ with negative ISH)
HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)
Disease stage
Excluded: Stage STAGE 4
with1-3 positive lymph nodes, T1-T2，and is ER+/HER2- confirmed by histopathology after early breast cancer surgery; Has metastatic (Stage 4) breast cancer [excluded]; Has any ≥T3 lesion [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: neoadjuvant therapy
Lab requirements
Blood counts
hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 10^9 /L; platelet count ≥ 100 x 10^9 /L
Kidney function
serum creatinine ≤ 1×ULN and endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula)
Liver function
ALT ≤ 3×ULN, AST ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN
Cardiac function
left ventricular ejection fraction (LVEF) ≥ 50% (cardiac ultrasound)
adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 10^9 /L; platelet count ≥ 100 x 10^9 /L; adequate liver and kidney function: ALT ≤ 3×ULN, AST ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN and endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula); left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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