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

Plain English Summary

Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer is a Phase 2 clinical trial sponsored by Sun Yat-sen University studying Breast Cancer, Triple Negative Breast Cancer (TNBC), Early Stage Breast Cancer, Immunotherapy, Probiotic. This study is testing if a probiotic called Biolosion, taken with standard chemotherapy, can improve treatment for a specific type of breast cancer. It is for women diagnosed with locally advanced triple-negative breast cancer. Participants will receive standard neoadjuvant therapy (chemotherapy before surgery) along with Biolosion, and will be monitored closely. Standard neoadjuvant chemotherapy is the current alternative, but this trial explores adding a probiotic to potentially enhance its effectiveness. The trial aims to enroll 192 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18 and older with a confirmed diagnosis of triple-negative breast cancer. Patients must have tumor tissue available for testing and be eligible for neoadjuvant chemotherapy. Individuals who have not received prior chemotherapy or targeted therapy for advanced breast cancer. Patients must have good general health, with specific requirements for blood counts and organ function, and women of childbearing potential must use reliable contraception. This trial is studying Breast Cancer, Triple Negative Breast Cancer (TNBC), Early Stage Breast Cancer, Immunotherapy, Probiotic, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures whether patients achieve a pathological complete remission, meaning no detectable cancer cells in the breast and lymph nodes after treatment, which is a strong indicator o The specific primary outcome measures are: Pathological complete remission (From enrollment to the end of treatment at 24 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for more effective treatments for triple-negative breast cancer, an aggressive form of the disease with limited options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, Triple Negative Breast Cancer (TNBC), Early Stage Breast Cancer, Immunotherapy, Probiotic, where improved treatment options are needed.

Investor Insight

This trial signals potential innovation in breast cancer treatment by exploring the use of probiotics to augment standard therapies, a growing area of interest in oncology. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific situation and if you meet all the eligibility requirements. Understand that participation involves receiving standard chemotherapy along with the study probiotic, and requires regular visits for treatment and monitoring. Be prepared for potential side effects from chemotherapy and the study drug, and ensure you can comply with all study procedures and follow-up appointments. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 192 participants

Interventions

• 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.

Primary Outcomes

• Pathological complete remission (From enrollment to the end of treatment at 24 weeks)

Secondary Outcomes

• overall survival (From enrollment to the end of treatment at 5 years)
• Disease Free Survival (From enrollment to the end of treatment at 5 years)

Full 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.

Trial Locations

• 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

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Triple Negative Breast Cancer (TNBC)
• Early Stage Breast Cancer
• Immunotherapy
• Probiotic
• Oncology
• Chemotherapy
• Neoadjuvant Therapy
• Gastrointestinal Health
• Cancer Research

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