Actively Recruiting
A Multicenter, Randomized Controlled Phase II Study of Standard Neoadjuvant Therapy with Biolosion in Triple-negative Breast Cancer
Led by Sun Yat-sen University · Updated on 2026-04-01
192
Participants Needed
5
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a compound preparation called Biolosion, taken alongside standard neoadjuvant therapy for women with locally advanced triple-negative breast cancer. This Phase II randomized study aims to compare the combined treatment to standard therapy alone. The study is sponsored by Sun Yat-sen University and focuses on patients who have not previously received chemotherapy or targeted therapy for advanced breast cancer. Participants will be randomly assigned to one of two groups. One group will receive standard therapy consisting of chemotherapy drugs (paclitaxel-carboplatin or docetaxel-carboplatin followed by doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide) combined with a PD-1 antibody, along with the oral probiotic Biolosion taken nightly for 21 days after each cycle. The other group will receive the same standard therapy without Biolosion. Treatment will last for 24 weeks. During the study, participants will be closely monitored with tumor tissue testing for PD-L1 expression, imaging, and pathology evaluations. Researchers will assess the primary outcome of pathological complete remission at the end of treatment. Secondary outcomes include overall survival and disease-free survival over five years. Safety assessments and follow-up visits will support adherence and measure treatment impact throughout the study period, which extends through long-term observation.
CONDITIONS
Brief 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 older diagnosed with triple-negative breast cancer confirmed by pathology
- Availability of tumor specimens for PD-L1 expression testing
- Indication 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 of 0 to 2
- Expected survival of at least 12 weeks
- Adequate major organ function according to specified hematological and biochemical criteria
- Women of childbearing age must use reliable contraception or have a negative pregnancy test before enrollment and agree to contraception during the trial and 8 weeks after
- Voluntary participation with good compliance and willingness to follow up
You will not qualify if you...
- Presence of distant metastasis
- History of autoimmune diseases
- Active hepatitis B or C infection as defined by specific markers
- Previous treatment with immune checkpoint inhibitors
- Use of systemic immunostimulants, corticosteroids, or immunosuppressants within 4 weeks
- Severe underlying diseases, active infections, or metabolic disorders
- Current antitumor treatments
- Comorbidities that increase risk or interfere with study drug use or results
- Use or planned use of probiotics, yogurt, or bacterial-enhanced foods during treatment
- History of epilepsy or seizure disorders
- Pregnant or breastfeeding
- Poor compliance or inability to follow up
- Allergy to the study drug
- Other malignancies diagnosed within 5 years except certain treated cancers
- Other conditions judged by the investigator to affect study conduct or results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive standard neoadjuvant chemotherapy combined with Biolosion or standard therapy alone as part of the randomized treatment regimen.
Regular visits corresponding to treatment cycles over 24 weeks
Duration - Up to 5 years
Participants are monitored for overall survival and disease-free survival after completing treatment.
Periodic follow-up visits for up to 5 years
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
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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