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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,900
aromatase inhibitors (± ovarian suppression) plus 3-year abemaciclib (100mg bid) without chemotherapy.
treatment of physician's choice including whether to receive chemotherapy, chemotherapy regimen and endocrine therapy regimen.
Zhimin Cancer Shao
Shanghai, China
RECRUITINGInvasive disease free survival
Time frame: 5 year
disease free survival
Time frame: 5 year
distant disease free survival
Time frame: 5 year
overall survival
Time frame: 5 year
Time Frame: 5 years] 5. adverse effects adverse effects
Time frame: 5 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.