NCT06768931

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Breast Cancer
• Triple Negative Breast Cancer (TNBC)
• Early Stage Breast Cancer
• Immunotherapy
• Probiotic

Interventions

Type	Name	Description
OTHER	Biolosion (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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-01-08
• Completion: 2035-02-08
• First posted: 2025-01-10
• Last updated: 2026-04-01

Locations

5 sites across 1 country: China