Actively Recruiting
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
Eligibility Criteria
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
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
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
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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