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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06341621 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior neoadjuvant therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression (ER≥50%) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (IHC 0, 1+, or 2+ with negative ISH) is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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