Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT05806060

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

Led by Fudan University · Updated on 2026-03-25

134

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 70 years
  • ECOG Performance Status of 0 or 1
  • Expected lifetime of at least three months
  • Histologically confirmed metastatic or locally advanced triple-negative breast cancer (TNBC) with basal-like immune suppressed (BLIS) subtype
  • Recurrent or metastatic breast cancer stage; local recurrence confirmed as unresectable
  • No prior chemotherapy or targeted therapy for metastatic TNBC
  • At least one measurable or non-measurable lesion not previously treated with radiation
  • Major organ functions are essentially normal
  • Women of childbearing potential agree to use contraception or remain abstinent as required
  • Ability to understand the study protocol and willingness to participate and follow up
Not Eligible

You will not qualify if you...

  • Symptomatic, untreated, or active central nervous system metastases
  • Significant cardiovascular disease
  • Ongoing Grade 1 or higher adverse reactions from previous treatments (except hair loss or exceptions noted by researchers)
  • Major surgery within 3 weeks before starting trial treatment (minor outpatient surgery allowed)
  • Pregnancy, breastfeeding, or plans to become pregnant during the study
  • Other cancers within the past 5 years, except cured cervical carcinoma in situ or certain skin cancers
  • Inability to swallow, chronic diarrhea, intestinal blockage affecting drug use or absorption
  • Uncontrolled fluid buildup like pleural fluid or ascites
  • Participation in other antitumor drug trials within 4 weeks before starting this trial
  • Long-term non-healing wounds or fractures
  • Active hepatitis B or C infection or abnormal liver function
  • Known allergies to trial drug components or other monoclonal antibodies
  • History or risk of gastrointestinal bleeding within the past 6 months
  • Abdominal fistula, gastrointestinal perforation, or abscess within 28 days before trial
  • Significant proteinuria or urine protein >1.0 g/24h
  • Hypertension not controlled to normal range despite treatment (systolic >140 mmHg or diastolic >90 mmHg)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Z

Zhimin Shao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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