The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
912
* HRS-8080 Tablet * Dalpiciclib Isethionate
* Fulvestrant injection * Dalpiciclib Isethionate
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China
RECRUITINGInvestigator assessed Progression free survival (PFS)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.
Time frame: Up to 5 years.
Progression free survival (PFS) evaluated by the blinded independent central review (BICR)
Time frame: Up to 5 years
Overall response rate (ORR)
Time frame: Up to 5 years
Clinical benefit rate (CBR)
Time frame: Up to 5 years
Duration of response (DOR)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 8 years
The incidence and severity of adverse events (AEs)
Time frame: Up to 5 years
The incidence and severity of serious adverse events (SAEs)
Time frame: Up to 5 years
Number of participants with vital sign abnormalities over the course of the study. Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature
Time frame: Up to 5 years
Number of participants with clinical laboratory test abnormalities for haematology and biochemistry parameters over the course of the study
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Time frame: Up to 5 years
Heart rate (beats per minute) measured by 12-lead electrocardiography.
Time frame: Up to 5 years
QT interval (ms) measured by 12-lead electrocardiography.
Eastern Cooperative Oncology Group (ECOG) performance status. ECOG performance status was measured on a 6 point grade scale. 0: Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead.
Time frame: Up to 5 years
Plasma concentrations of HRS-8080 and dalpiciclib isethionate
Time frame: Up to approximately 2 years