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

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Description

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.

Study Overview

Start Date
April 25, 2023
Completion Date
February 28, 2026
Enrollment
192
Date Posted
April 10, 2023
Accepts Healthy Volunteers?
No
Gender
Female

Locations

Full Address
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai 200032, China

Eligibility

Minimum Age (years)
18
Maximum Age (years)
70
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)

Study Contact Info

Study Contact Name
Zhimin Shao
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05806060