The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
156
During HRS-8080 monotherapy period, the dose of HRS-8080 would be increasing. In the combination therapy period, HRS-8080 will be administered at flat dose of RP2D-1 and RP2D.
Fifth Medical Center of People's Liberation Army of China General Hospital
Beijing, Beijing Municipality, China
Jilin Cancer Hospital
Changchun, Jilin, China
Maximum tolerated dose
The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Time frame: up to 28 days
Recommended phase II dose
The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Time frame: up to 28 days
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: up to 30 days after the last dose
Cmax
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Tmax
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc.
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
AUC0-t
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Cmax,ss
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PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Tmax,ss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Cmin,ss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
AUCss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Rac
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
ORR
Objective Response Rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
BOR
Best Overall Response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
DoR
Duration of response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
DCR
Disease control rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
PFS
Progression-free survival, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months