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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer (NCT06768931) is a Phase 2 interventional studying Breast Cancer and Triple Negative Breast Cancer (TNBC), sponsored by Sun Yat-sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Breast Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 192 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Breast Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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: white blood cell count (ANC) at least 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 kidney function (creatinine clearance) at least 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. Who Should NOT Join This Trial: 1. There is a clear distant transfer; 2. A history of autoimmune conditions (where your immune system attacks your own body)s; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06768931), the sponsor (Sun Yat-sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06768931 clinical trial studying?

To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06768931?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06768931?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06768931. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06768931. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.