The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,500
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGThe time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause.
Invasive Breast Cancer-Free Survival (IBCFS).
Time frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Invasive Disease-Free Survival (IDFS).
Time frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Distant Metastasis-Free Survival (DRFS).
Time frame: At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.
Overall Survival (OS).
Time frame: Survival follow-up every 3 months, up to 5 years.
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Anastrozole tablets.
Exemestane tablets.