This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,903
Standard endocrine therapy
CDK4/6 inhibitor therapy for 2 years in combination with standard endocrine therapy
Fudan cancer center
Shanghai, China
RECRUITING5-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
Distant Recurrence-Free Survival (DRFS)
DRFS is defined as the time interval from the start of cancer treatment to the first occurrence of distant metastasis or 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
Patient-Reported Outcome (PRO)
Patient-Reported Outcome (PRO) refers to a report that comes directly from the patient on her health status, functional status, and experience of treatment, without interpretation by healthcare or other personnel (e.g., symptoms, quality of life, physical functioning, etc.), and is usually collected through standardized questionnaires or scales. Lower scores in European Organization for Research and Treatment of Cancer(EORTC) QLQ-BR45 questionnaire will mean a better outcome.
Time frame: Up to approximately 3 years
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