This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant endocrine therapy in breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,388
Dalpicilib 100 mg once daily from day 1 to day 21, every 4 weeks, for a total of 3 years, in combination with endocrine therapy for 5 years.
standard endocrine therapy
breast cancer institute of Fudan University Cancer Hospital, shanghai, shanghai
Shanghai, China
Invasive Disease Free Survival
Invasive Disease Free Survival
Time frame: From enrollment to 3 years post-treatment
3-Year Disease-Free Survival
Time frame: From enrollment to 3 years post-treatment
Overall Survival
Overall Survival
Time frame: From enrollment to 3 years post-treatment
safety
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From enrollment to 3 years post-treatment
Patient reported outcomes
Patient-Reported Outcomes (PROs) Assessed by the EORTC QLQ-C30 Questionnaire. Provide a brief description of what aspects of the patient's health or experience the tool will measure (e.g., quality of life, symptom burden, treatment side effects).
Time frame: From enrollment to 3 years post-treatment
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