Breast CancerPhase 2NCT06768931
Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
A Phase 2 study testing Biolosion (oral probiotic compound preparation) in people with Breast Cancer and Triple Negative Breast Cancer (TNBC), run by Sun Yat-sen University at 5 sites in China.
Trial summary
To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer (TNBC), Early Stage Breast Cancer
- What is being tested?
- Biolosion (oral probiotic compound preparation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 5 sitesChina
- Study dates
- 1 Apr 2026to 8 Feb 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;
- Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;
- 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;
- Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;
- ECOG PS: 0-2;
- Expected survival of ≥12 weeks;
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- 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.
Who cannot join
- There is a clear distant transfer;
- A history of autoimmune diseases;
- 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.
- Previous treatment with immune checkpoint inhibitors;
- Received systemic immunostimulants, systemic corticosteroids, or immunosuppressants within the last 4 weeks;
- Any severe underlying disease, comorbidities, and active infections, or patients with severe metabolic disorders;
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- Currently receiving other antitumor treatments;
- 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.
- Currently using or planning to use probiotics, yogurt, or bacterial-enhanced foods during the treatment period.
- A history of epilepsy or seizure-inducing states;
- Pregnant or breastfeeding patients;
- Poor compliance or inability to undergo normal follow-up;
- Individuals allergic to the study drug;
- 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;
- The investigator's judgment on other conditions that may affect the conduct of the clinical study and the determination of study results.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Dongguan People's Hospital
Dongguan, Guangdong, 523059
Qinglin Tan, Doctor, 0769-28637333, 51845122@qq.com
- Recruiting
Sun yat sen university cancer center
Guangzhou, Guangdong, 510060
Meiting Chen, Doctor, 02087341812, chenmt@sysucc.org.cn
chenmt@sysucc.org.cn
- Not yet recruiting
Gansu Cancer Hospital
Lanzhou, Gansu, 730050
Xu Luo, Doctor, 0931-2302548, doctor_luoxu@126.com
- Not yet recruiting
Central Hospital of Guangdong Nongken
Zhanjiang, Guangdong, 524002
Rishang Chen, Doctor, crs4529068@163.com
- Not yet recruiting
Zigong Fourth People's hospital
Zigong, Sichuan, 643000
Xiaobo Zhou, 0813-2401026, zg_120@126.com
About this study
Official title: 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
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), Early Stage Breast Cancer, Immunotherapy, Probiotic
- Being tested
- Biolosion (oral probiotic compound preparation)
- Keywords
- Triple negative breast cancer, Probiotics, Immunotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biolosion (oral probiotic compound preparation)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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 Receives: Other: Biolosion (oral probiotic compound preparation) |
| Controlled group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission
ypT0N0, ypTisN0 after surgery
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (2)
overall survival
The length of time from the date of the start of treatment until death.
Measured: From enrollment to the end of treatment at 5 years
Disease Free Survival
Time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment.
Measured: From enrollment to the end of treatment at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Apr 2026 (estimated)
- Primary completion8 Jan 2030 (estimated)
- Study completion8 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in experimental group will be treated with standard neoadjuvant chemotherapy, immunotherapy combined with Biolosion (oral probiotic compound preparation). Patients in controlled group will be treated with standard neoadjuvant chemotherapy and immunotherapy.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meiting Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768931
- Sponsor's protocol ID
- SYSUCC-BC-PROBIOTIC
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Phase II Clinical Study of Standard Neoadjuvant Therapy Combined With Biolosion (Oral Probiotic Compound Preparation) in Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06768931
- Acronym / sponsor ID
- SYSUCC-BC-PROBIOTIC
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), Early Stage Breast Cancer, Immunotherapy, Probiotic
- Keywords
- Triple negative breast cancer, Probiotics, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 8 Jan 2030 (estimated)
- Study completion
- 8 Feb 2035 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in experimental group will be treated with standard neoadjuvant chemotherapy, immunotherapy combined with Biolosion (oral probiotic compound preparation). Patients in controlled group will be treated with standard neoadjuvant chemotherapy and immunotherapy.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Biolosion (oral probiotic compound preparation)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 |
| Controlled group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;
- Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;
- 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;
- Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;
- ECOG PS: 0-2;
Key exclusion criteria (15 listed)
- There is a clear distant transfer;
- A history of autoimmune diseases;
- 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.
- Previous treatment with immune checkpoint inhibitors;
- Received systemic immunostimulants, systemic corticosteroids, or immunosuppressants within the last 4 weeks;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental group |
Primary outcome
Pathological complete remission
Time frame: From enrollment to the end of treatment at 24 weeks
ypT0N0, ypTisN0 after surgery
2 secondary outcomes
overall survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biolosion (oral probiotic compound preparation) in people with Breast Cancer and Triple Negative Breast Cancer (TNBC), run by Sun Yat-sen University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meiting Chen, Doctor (020-87343368, chenmt@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.