Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

• Status: Recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine; Carboplatin; Paclitaxel; Vinorelbine

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)

• 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

• Active hepatitis B or hepatitis C

• History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study

• History of gastrointestinal bleeding within 6 months or any serious bleeding events

• Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study

• Long-term unhealing wound or incomplete healing of fracture

• Urine protein ≥2+ and 24h urine protein quantitative > 1 g

• Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)