This is a multi-center, open-lable, prospective, randomized phase III clinical trial to investigate the efficacy and safety of adjuvant ribociclib combined with aromatase inhibitor in hormone receptor-positive, HER2-negative early breast cancer with residual disease after neoadjuvant chemotherapy
Willingness for study participation with written informed consent
Female with age at least 18 years
Histologically confirmed unilateral or bilateral primary invasive breast cancer
Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion
c/pN+
Known severe hypersensitivity reactions to compounds similar to ribociclib or to aromatase inhibitor
Inadequate organ function immediate prior to randomization including: Hemoglobin <10g/dL (100g/L); ANC < 2000/mm³ (< 2.0 x 10^9/L); Platelets <100,000/mm³ (< 100 x 10^9/L); AST or ALT >1.5 x upper limit of normal (ULN); alkaline phosphatase > 2.5 x ULN, total serum bilirubin > 1.25 x ULN; serum creatinine >1.25 x ULN or estimated creatinine clearance < 60 mL/min as calculated using the method standard for the institution; severe and relevant co-morbidity that would interact with the participation in the study
Evidence for infection including wound infections, Human Immunodeficiency Virus (HIV) or any type of Hepatitis