precise treatment for blis subtype of tnbc in the first-line treatment of locally advanced or metastatic breast cancer

Conditions: Triple-Negative Breast Cancer

Summary: the study is being conducted to evaluate vegfr bp102 with nab-paclitaxe or treatment of physician's choice (tpc) versus nab-paclitaxe or tpc in patients for basal-like immune suppressed (blis) subtype of triple-negative breast cancer (tnbc) in the first-line teatment of unresectable locally advanced or metastatic tnbc.


Eligibility criteria:
inclusion criteria: * ecog performance status of 0-1 * expected lifetime of not less than three months * metastatic or locally advanced, histologically documented tnbc (absence of her2, er, and pr expression) with blis subtype * cancer stage: recurrent or metastatic breast cancer; local recurrence be confirmed by the researchers could not be radical resection * patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer * at least one measurable or non-measurable lesion according to response evaluation criteria in solid tumors v1.1 (recist v1.1), which didn't receive radiation therapy * the functions of major organs are basically normal * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm * have the cognitive ability to understand the protocol and be willing to participate and to be followed up exclusion criteria: * symptomatic, untreated, or actively progressing cns metastases * significant cardiovascular disease * adverse reactions of grade ≥1 that are still continuing due to previous treatments. exceptions are those of hair loss or which researchers take it as exception * major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access) * pregnancy or breastfeeding, or intention of becoming pregnant during the study * other malignancies within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma * inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the use and absorption of drugs * presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites) * participated in clinical trials of other antitumor drugs within 4 weeks before first taking the investigational drug * long-term unhealing wound or incomplete healing of fracture * patients with known active hbv or hcv infection or hepatitis b dna≥500, or chronic phase with abnormal liver function * allergic constitution, or known allergic history of the drug components of this trial; or allergic to other monoclonal antibodies * patients with a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), were not allowed to enter the group; if there is occult blood in the stool (+), gastroscopy is required * abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this trial * urine protein ≥2+ and 24h urine protein quantitative \> 1.0 g * patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure \>140mmhg, diastolic blood pressure \>90mmhg)