chemotherapy omission in er+/her2- breast cancer with 1-3 positive lymph nodes receiving extended adjuvant abemaciclib

Conditions: Breast Cancer

Summary: 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

this is a prospective, randomized, open-label, multicenter phase iii study to explore chemotherapy omission in estrogen receptor (er)-positive, human epidermal growth factor receptor 2 (her2)-negative endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib. in this study, patient eligible will be randomized into either endocrine drug plus 3-year adjuvant abemaciclib without chemotherapy or treatment of physician's choice (tpc).the safety and efficacy of each group will be assessed through invasive disease free survival (idfs), disease-free survival (dfs), distant disease free survival (ddfs), overall survival (os) and adverse effects (ae) as graded by common terminology criteria for adverse events (ctcae) 5.0.

Eligibility criteria:
inclusion criteria: * women aged 18-80 years old; * patient has localized invasive breast carcinoma with1-3 positive lymph nodes, t1-t2，and is er+/her2- confirmed by histopathology after early breast cancer surgery#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) . * er≥50% * has an eastern cooperative oncology group (ecog) performance status of 0 or 1; * has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/l (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /l; platelet count ≥ 100 \* 109 /l; (2)adequate liver and kidney function: alanine aminotransferase (alt) ≤ 3×upper limit of normal (uln), aspartate aminotransferase (ast) ≤ 3×uln, total bilirubin (tbil)≤ 1.5×uln, serum creatinine ≤ 1×uln#and with endogenous creatinine clearance rate of \>50 ml/min (cockcroft-gault formula). * participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. exclusion criteria: * has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy#; * has bilateral breast cancer; * has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. * has metastatic (stage 4) breast cancer; * has any ≥t3 lesion * is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; * patients participating in other clinical trials at the same time; * has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (lvef) \ 150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; * has severe or uncontrolled infection; * the researchers judged patients to be unsuitable for the study.

Keywords: adjuvant chemotherapy omission adjuvant abemeciclib