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

March 26, 2026 updated by: Meiting Chen, Sun Yat-sen University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

192

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Cancer Hospital
        • Contact:
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Not yet recruiting
        • Dongguan People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat Sen University Cancer Center
        • Principal Investigator:
          • Yanxia Shi, Doctor
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Meiting Chen, Doctor
        • Sub-Investigator:
          • Haifeng Li, Doctor
        • Sub-Investigator:
          • Riqing Huang, Doctor
      • Zhanjiang, Guangdong, China, 524002
        • Not yet recruiting
        • Central Hospital of Guangdong Nongken
        • Contact:
    • Sichuan
      • Zigong, Sichuan, China, 643000
        • Not yet recruiting
        • Zigong Fourth People's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;
  2. Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;
  3. Researchers assess indications for neoadjuvant chemotherapy, with staging from IIA to IIIC, based on imaging or pathological evaluation of cT1c, N1-3, or cT2~cT4, cN0~N3, and patients with no distant metastasis as evaluated by imaging;
  4. Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;
  5. ECOG PS: 0-2;
  6. Expected survival of ≥12 weeks;
  7. Major organ function levels must meet the following criteria:

1) Hematological examination standards must meet: ANC≥1.5×10^9/L, PLT≥75×10^9/L, Hb≥90g/L (no blood transfusions or blood products within 14 days, and no use of G-CSF or other hematopoietic growth factors for correction) 2) Biochemical examination must meet the following standards: TBIL<1.5×ULN, ALT, AST<2.5×ULN, for patients with liver metastasis, ALT, AST may be <5×ULN, BUN and Cr≤1×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug.

9. Participants voluntarily join this study, demonstrate good compliance, and cooperate with follow-up.

Exclusion Criteria:

  1. There is a clear distant transfer;
  2. A history of autoimmune diseases;
  3. Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies/ml or ≥200 IU/ml) or positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment.
  4. Previous treatment with immune checkpoint inhibitors;
  5. Received systemic immunostimulants, systemic corticosteroids, or immunosuppressants within the last 4 weeks;
  6. Any severe underlying disease, comorbidities, and active infections, or patients with severe metabolic disorders;
  7. Currently receiving other antitumor treatments;
  8. Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.) that, in the investigator's assessment, would increase the risk associated with the administration of the study drug or interfere with the interpretation of study results.
  9. Currently using or planning to use probiotics, yogurt, or bacterial-enhanced foods during the treatment period.
  10. A history of epilepsy or seizure-inducing states;
  11. Pregnant or breastfeeding patients;
  12. Poor compliance or inability to undergo normal follow-up;
  13. Individuals allergic to the study drug;
  14. Diagnosis of other malignancies within the past 5 years, with the exception of: surgically removed non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally curative prostate cancer, surgically treated ductal carcinoma in situ, or malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years;
  15. The investigator's judgment on other conditions that may affect the conduct of the clinical study and the determination of study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Standard therapy (paclitaxel-carboplatin or docetaxel-carboplatin, and PD-1 antibody for 4 cycles followed by doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide, and PD-1 antibody for 4 cycle) combined with compound preparation Biolosion
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.
No Intervention: Controlled group
Standard therapy, including paclitaxel-carboplatin or docetaxel-carboplatin, and PD-1 antibody for 4 cycles followed by doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide, and PD-1 antibody for 4 cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete remission
Time Frame: From enrollment to the end of treatment at 24 weeks
ypT0N0, ypTisN0 after surgery
From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: From enrollment to the end of treatment at 5 years
The length of time from the date of the start of treatment until death.
From enrollment to the end of treatment at 5 years
Disease Free Survival
Time Frame: From enrollment to the end of treatment at 5 years
Time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment.
From enrollment to the end of treatment at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 8, 2030

Study Completion (Estimated)

February 8, 2035

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-BC-PROBIOTIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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