An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab in First to Third Line BLIS Subtype TNBC

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.

Inclusion Criteria: 1. Female patients aged ≥18 years and ≤70 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 3. Life expectancy of at least 3 months; 4. 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 \1.0 g; 15. Hypertension that cannot be controlled to within normal range with antihypertensive medication (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg); 16. Prior use of anti-angiogenic agents or prior exposure to an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as the payload