RecruitingPhase 2NCT06768931

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

A Multicenter, Randomized Controlled Phase II Clinical Study of Standard Neoadjuvant Therapy Combined With Biolosion (Oral Probiotic Compound Preparation) in Triple-negative Breast Cancer


Sponsor

Sun Yat-sen University

Enrollment

192 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing Biolosion — an investigational drug — combined with standard neoadjuvant chemotherapy (chemotherapy given before surgery) for women with triple-negative breast cancer. Triple-negative breast cancer is a more aggressive subtype that does not respond to hormone therapies or HER2-targeted treatments. **You may be eligible if...** - You are a woman aged 18 or older diagnosed with triple-negative breast cancer (confirmed by pathology: ER ≤10%, PR ≤10%, HER2-negative) - Your cancer is stage IIA to IIIC (locally advanced but not yet spread to distant organs) - You have not yet received chemotherapy or targeted therapy for this cancer - A tumor tissue sample is available for testing - Your general health is good (ECOG score 0-2) and you have adequate organ function **You may NOT be eligible if...** - You have received prior chemotherapy or targeted therapy for advanced breast cancer - You have distant metastases - Your expected survival is less than 12 weeks - You have serious underlying health conditions affecting heart, liver, or kidney function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBiolosion (oral probiotic compound preparation)

Biolosion (oral probiotic compound preparation) will be administered in the experimental arm. Biolosion will be taken every night from day 1 to day 21 after each cycle of immunotherapy-chemotherapy.


Locations(5)

Gansu Cancer Hospital

Lanzhou, Gansu, China

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun yat sen university cancer center

Guangzhou, Guangdong, China

Central Hospital of Guangdong Nongken

Zhanjiang, Guangdong, China

Zigong Fourth People's hospital

Zigong, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06768931


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