This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype. A total of 140 patients are planned to be enrolled.
Female patients aged ≥18 years and ≤70 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
Life expectancy of at least 3 months;
Histologically confirmed invasive triple-negative breast cancer (defined as breast cancer with estrogen receptor [ER], progesterone receptor [PR], and human epidermal growth factor receptor 2 [HER-2] all determined to be negative by pathological testing. Specifically: ER-negative: IHC <1%; PR-negative: IHC <1%; HER2-negative: IHC -/+ or IHC ++ with FISH/CISH negative. All specimens must be verified as the BLIS subtype of the Fudan quadruple molecular classification by the Precision Medicine Center/Department of Pathology at the study's participating center);
Known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the first dose to rule out CNS metastases;
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;
Persistent adverse events of Grade ≥1 resulting from prior treatment. Exceptions to this are alopecia or conditions that the investigator deems should not preclude enrollment. Such cases should be clearly documented in the investigator's notes;
Major surgery (excluding minor procedures such as placement of vascular access) within 3 weeks before the first cycle of study treatment;
Parallel
SHR- A1811
DrugSHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle.
SHR-A1811+BEV
DrugSHRA1811(HER-targeted ADC) at 4.8 mg/kg in combination with BEV(bevacizumab) at 15 mg/kg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.
Progression Free Survival(PFS)
Time to progressive disease (according to RECIST1.1)
Objective response rate (ORR)
Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Duration of Response (DoR)
the time from the first documented objective response (complete response or partial response) to the first documented disease progression or death from any cause, whichever occurs first.
Disease Control Rate (DCR)
The proportion of evaluable patients who achieve Complete Response (CR) , Partial Response (PR) , or Stable Disease (SD) after treatment.
Overall survival (OS)
Time from the enrollment to death of any cause
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
