Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06768931

Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer

Led by Sun Yat-sen University · Updated on 2026-04-01

192

Participants Needed

5

Research Sites

462 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer

CONDITIONS

Official Title

Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years and above diagnosed with triple-negative breast cancer (ER ≤10%, PR ≤10%, HER-2 negative) by pathology
  • Availability of tumor specimens for PD-L1 expression testing
  • Indicated for neoadjuvant chemotherapy with staging from IIA to IIIC and no distant metastasis
  • No prior chemotherapy or targeted therapy for advanced breast cancer
  • ECOG performance status 0 to 2
  • Expected survival of at least 12 weeks
  • Adequate major organ function with specified hematological and biochemical criteria
  • Women of childbearing age must use reliable contraception or have a negative pregnancy test within 7 days prior to enrollment and agree to contraception during and 8 weeks after treatment
  • Voluntary participation with good compliance and cooperation with follow-up
Not Eligible

You will not qualify if you...

  • Presence of clear distant metastasis
  • History of autoimmune diseases
  • Acute or chronic active hepatitis B or hepatitis C infection
  • Previous treatment with immune checkpoint inhibitors
  • Use of systemic immunostimulants, corticosteroids, or immunosuppressants within the last 4 weeks
  • Severe underlying diseases, comorbidities, active infections, or severe metabolic disorders
  • Current antitumor treatments
  • Known comorbidities that increase risk or interfere with study results
  • Use or planned use of probiotics, yogurt, or bacterial-enhanced foods during treatment
  • History of epilepsy or seizure-inducing conditions
  • Pregnant or breastfeeding women
  • Poor compliance or inability to complete follow-up
  • Allergy to study drug
  • Other malignancies diagnosed within the past 5 years, except certain treated cancers
  • Other conditions affecting study conduct or result determination as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Gansu Cancer Hospital

Lanzhou, Gansu, China, 730050

Not Yet Recruiting

2

Dongguan People's Hospital

Dongguan, Guangdong, China, 523059

Not Yet Recruiting

3

Sun yat sen university cancer center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

4

Central Hospital of Guangdong Nongken

Zhanjiang, Guangdong, China, 524002

Not Yet Recruiting

5

Zigong Fourth People's hospital

Zigong, Sichuan, China, 643000

Not Yet Recruiting

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Research Team

M

Meiting Chen, Doctor

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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