Using Biolosion with standard 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

This study is testing if adding a new oral probiotic called Biolosion to standard treatment can help women with locally advanced triple-negative breast cancer have better outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Lanzhou, Gansu and 4 other locations)
• Trial ID: NCT06768931 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Biolosion, an oral probiotic compound, when combined with standard neoadjuvant therapy for women diagnosed with locally advanced triple-negative breast cancer. Participants will be assessed for eligibility based on specific criteria, including tumor characteristics and overall health status. The trial aims to determine if this combination can improve treatment outcomes for patients with this aggressive form of breast cancer.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 years and older with a confirmed diagnosis of triple-negative breast cancer who have not received prior chemotherapy for advanced disease.

Not a fit: Patients with distant metastasis or those who have previously undergone chemotherapy or targeted therapy for advanced breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment effectiveness and improve survival rates for patients with triple-negative breast cancer.

How similar studies have performed: While the use of probiotics in cancer treatment is an emerging field, this specific combination approach has not been widely tested, making it a novel investigation.

Eligibility criteria

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.

Where this trial is running

Lanzhou, Gansu and 4 other locations

• Gansu Cancer Hospital — Lanzhou, Gansu, China (NOT_YET_RECRUITING)
• Dongguan People's Hospital — Dongguan, Guangdong, China (NOT_YET_RECRUITING)
• Sun yat sen university cancer center — Guangzhou, Guangdong, China (RECRUITING)
• Central Hospital of Guangdong Nongken — Zhanjiang, Guangdong, China (NOT_YET_RECRUITING)
• Zigong Fourth People's hospital — Zigong, Sichuan, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Meiting Chen, Doctor

Conditions: Breast Cancer, Triple Negative Breast Cancer, Early Stage Breast Cancer, Immunotherapy, Probiotic, Triple negative breast cancer, Probiotics