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
Parallel
Ribociclib plus aromatase inhibitor
DrugRibociclib (oral 600 mg once daily for 3 weeks on, 1 week off) plus daily aromatase inhibitor (letrozole oral 2·5 mg/day, anastrozole oral 1 mg/day, or exemestane oral 5 mg/day)
Aromatase inhibitor
DrugDaily aromatase inhibitor (letrozole oral 2·5 mg/day, anastrozole oral 1 mg/day, or exemestane oral 5 mg/day)
3-year invasive disease-free survival
The time from random assignment until the presence of invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, invasive contralateral breast cancer, second primary invasive cancer (non-breast), or any-cause death assessed by the investigator
3-year recurrence-free survival
The time from random assignment until the presence of invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, or any-cause death assessed by the investigator
3-year distant disease-free survival
The time from random assignment until the presence of distant recurrence, second primary invasive cancer (non-breast), or any-cause death assessed by the investigator
3-year overall survival
The time from random assignment until any-cause death assessed by the investigator
Health-related quality of life 1
The score of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30)
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