This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Apatinib is a kind of TKI inhibitor.
Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.
Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Progression Free Survival (PFS)
The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.
Time frame: Approximately 5 years
Clinical Benefit Rate (CBR)
CBR is the total percentage of participants who achieved a complete response, partial response, or had stable disease for 6 months or more.
Time frame: Approximately 5 years
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Time frame: Approximately 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 and tolerability
Number of adverse events according to NCI-CTCAE Version 5.0 per each treatment arm.
Time frame: Approximately 5 years
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