The main purpose of this study was to evaluate the efficacy and safety of treatment with famitinib plus SHR6390 and endocrine therapy for hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor (HER) 2 - negative advanced breast cancer.
This study would enroll patients with hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor (HER) 2 - negative advanced breast cancer, aimed to evaluate the efficacy and safety of treatment with famitinib combined with SHR6390 and endocrine therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Famitinib orally, daily or every other day
SHR6390 orally, daily for 3 weeks followed by 1 week off
Fulvestrant
Henan Cancer Hospital
Zhengzhou, Henan, China
RP2D in phase Ib
Recommended phase II dose (PR2D) in phase Ib
Time frame: Up to 4 weeks
ORR in phase II
Objective response rate (ORR) by investigator in phase II
Time frame: up to 2 years
ORR in phase Ib
ORR by investigator in phase Ib
Time frame: up to 2 years
PFS in phase Ib
Progression-Free Survival (PFS) in phase Ib
Time frame: up to 2 years
PFS in phase II
Progression-Free Survival in phase II
Time frame: up to 2 years
AE
The number of patients experiencing any adverse events (AE) during the phase II study time
Time frame: up to 2 years
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