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New treatment option for Breast Cancer
Official title Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT06768931
What this study is testing
- What it's testing
- To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;
- ECOG PS: 0-2;
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 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...
- Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;
- ECOG PS: 0-2;
- Expected survival of ≥12 weeks;
- 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...
- 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...
- 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;
- 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...
- 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...
- The investigator's judgment on other conditions that may affect the conduct of the clinical study and the determination of study results.
The study team makes the final eligibility decision.
Where it's taking place
- Lanzhou, Gansu, China
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Zhanjiang, Guangdong, China
- Zigong, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lanzhou, Gansu, China; Dongguan, Guangdong, China; Guangzhou, Guangdong, China; Zhanjiang, Guangdong, China; Zigong, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.