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;