This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \>65 years) with lymph node-positive, HR+/HER2- breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,244
Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.
All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)
Endocrine therapy (letrozole/anastrozole/exemestane)
5-years Invasive disease free survival
5-year invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of: local recurrence, distant metastasis, contralateral invasive breast cancer, death from any cause.
Time frame: 5 years
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: Approximately 5 years
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).
Incidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.
Time frame: Up to approximately 3 years
Geriatric assessment (G-8)
• Modified Geriatric-8 (G-8) screening tool
Time frame: Up to approximately 3 years
Clinical Frailty Scale
Clinical Frailty Scale (CFS, version 2.0)
Time frame: Up to approximately 3 years
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