The study is being conducted to assess the efficacy and safety of SHR6390 combined with famitinib in the treatment of advanced or metastatic breast cancer that progress in 1-2 line endocrine therapy.
This is a single-center, single-arm, open-label, Simon's two-stage design, phase II clinical trial. The purpose of this study was to evaluate the efficacy and safety of SHR6390 combined with famitinib in the treatment of HR+/HER2 advanced or metastatic breast cancer patients who have progressed during or after 1-2 line endocrine therapy. Subjects will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, and investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Breast Oncology, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Objective response rate (ORR)
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to RECIST 1.1.
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 30 months.
Clinical benefit rate (CBR)
Clinical benefit defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) lasting \>= 24 weeks, as determined by the Investigator according to RECIST v1.1.
Time frame: Randomization in participants with measurable disease at baseline through the end of study (12 months after the last participant is enrolled).
Duration of Remission (DoR)
Defined as the time from the first CR or PR to the first assessment of PD or death, whichever comes first.
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 30 months.
Progression Free Survival (PFS)
Time frame: Randomization to the first occurrence of disease progression as determined by the investigator according to (RECIST v1.1 ) or death from any cause, until the end of study (12 months after the last participant is enrolled)
Overall Survival (OS)
Time frame: Randomization to the first occurrence of disease progression as determined by the investigator according to (RECIST v1.1 ) or death from any cause, until the end of study (12 months after the last participant is enrolled)
Safety Profile
Safety will be assessed using NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE) for reporting laboratory and non-laboratory toxicities.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From the first medication to 28 days after the end of treatment.