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OncoMatch/Clinical Trials/NCT06768931

Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer

Is NCT06768931 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for breast cancer.

Phase 2RecruitingSun Yat-sen UniversityNCT06768931Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Biomarker criteria

Required: ESR1 ≤10% expression (≤10%)

ER≤10%

Required: PR (PGR) ≤10% expression (≤10%)

PR≤10%

Required: HER2 (ERBB2) negative (negative)

HER-2 negative

Required: PD-L1 (CD274) expression testing required

tumor specimens ... available for PD-L1 expression testing

Disease stage

Required: Stage IIA, IIB, IIIA, IIIB, IIIC

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: chemotherapy

Exception: for advanced breast cancer

Patients must not have received chemotherapy or targeted therapy for advanced breast cancer

Cannot have received: targeted therapy

Exception: for advanced breast cancer

Patients must not have received chemotherapy or targeted therapy for advanced breast cancer

Cannot have received: immune checkpoint inhibitor

Previous treatment with immune checkpoint inhibitors

Lab requirements

Blood counts

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)

Kidney function

bun and cr≤1×uln or endogenous creatinine clearance ≥50ml/min (cockcroft-gault formula)

Liver function

tbil<1.5×uln, alt, ast<2.5×uln, for patients with liver metastasis, alt, ast may be <5×uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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