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Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT05806060•Fudan University

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

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
+6 more criteria

Locations (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 25, 2023

Primary Completion Date

May 1, 2026

Completion Date

November 1, 2026

Last Updated

February 24, 2026

Enrollment

134

ESTIMATED participants

Conditions

Triple-Negative Breast Cancer

Interventions

VEGFR and TPC

DRUG

TPC

DRUG

Contacts

Zhimin Shao

CONTACT

86-021-64175590 zhimingshao@yahoo.com

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

NCT05914961

TNBC - Triple-Negative Breast Cancer

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RECRUITINGNA

Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

NCT03017573

Ovarian CancerTriple-Negative Breast Cancer+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

Reverse Triple Negative Immune Resistant Breast Cancer

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