This study is a multicenter, open, non-randomized phase II clinical trial consisting of a safety introduction phase followed by a single-arm phase 2 phase. This phase II trial enrolled patients with HR+/HER2- advanced breast cancer who had failed aromatase inhibitor (AI)/fulvestrant ± CDK4/6i. Pts failing prior AI ± CDK4/6i received nab-Sirolimus + fulvestrant, while those failing fulvestrant ± CDK4/6i received nab-Sirolimus + AI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Oral administration at a dose of 2.5 mg once daily for a 4-week cycle
Oral administration at a dose of 1 mg once daily for a 4-week cycle
Oral administration at a dose of 25 mg once daily with a meal every 4 weeks
Fulvestrant: IM injection, 500 mg, on day 1 and day 15 of Cycle 1, and then on day 1 of each cycle thereafter, 4 weeks per treatment cycle
IV infusion, every 2 weeks, 4 weeks per treatment cycle
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Objective Response Rate (ORR)
Time frame: Up to ~24 months
Disease Control Rate (DCR)
Time frame: Up to ~36 months
Duration of Response (DoR)
Time frame: Up to ~24 months
Progression-Free Survival (PFS)
Time frame: Up to ~24 months
Overall Survivial (OS)
Time frame: Up to ~24 months
Safety and Tolerability :the incidence and severity of Treatment Emergent Adverse Events(TEAEs)and Treatment-Related Adverse Events(TRAEs)
Time frame: Up to ~24 months
PK parameter: the concentration of sirolimus
Time frame: Up to ~24 months
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