This study is being conducted to evaluate the efficacy and safety of SHR-A1811 and Fulvestrant in Combination with or without HS-10352 in locally advanced or metastatic breast cancer patients. Subjects will receive SHR-A1811 and Fulvestrant in Combination with or without HS-10352.
This study plans to enroll breast cancer patients whose disease progressed during treatment or within 12 months of completing adjuvant therapy and who have not received prior systemic therapy. SHR-A1811 + fulvestrant group will receive treatment with SHR-A1811 and fulvestrant. HS-10352 group will receive treatment with SHR-A1811, fulvestrant, and HS-10352. Treatment will continue until disease progression or the occurrence of intolerable toxicity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular
SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular ; HS-10351 is administered orally
Objective Response Rate (ORR) according to RECIST1.1 (SHR-A1811+fulvestrant group and HS-10352 group (Phase II))
ORR defined as the proportion of patients with the best overall response of complete response or partial response,as determined by the investigator according to RECIST v1.1
Time frame: Up to approximately 4 years
Recommended Phase 2 dose (RP2D) (HS-10352 group (Phase Ib))
Time frame: From the first dose to the last dose of the first cycle defined as 28 days
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (SHR-A1811 + fulvestrant group and HS-10352 group (Phase II))
Evaluate the incidence and severity of adverse events according to CTCAE 5.0
Time frame: Up to approximately 4 years
Objective Response Rate (ORR) according to RECIST1.1 (HS-10352 group(Phase Ib))
ORR defined as the proportion of patients with the best overall response of complete response or partial response,as determined by the investigator according to RECIST v1.1
Time frame: Up to approximately 4 years
Progression-Free Survival (PFS)(SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II))
PFS is defined as the time from the first therapeutic dose to death or disease progression
Time frame: Up to 4 years
Overall Survival (OS) (SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II))
OS is defined as the time from the first therapeutic dose to death from any cause
Time frame: Up to 4 years
Clinical Benefit Rate (CBR) (CR+ PR+ SD≥24weeks)(SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II))
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CBR is defined as the percentage of participants with a CR, PR, and/or stable disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1
Time frame: Up to 4 years
Duration of Response (DOR) (SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II))
DOR is defined as the time from the first occurrence of a CR or PR to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first)
Time frame: Up to 4 years