OncoMatch

OncoMatch/Clinical Trials/NCT06768931

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

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

Phase 2RecruitingSun Yat-sen UniversityNCT06768931Data as of Jun 2026Location: China

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)

Demographics

Female only

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.

Frequently asked questions

Is NCT06768931 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ESR1?

Yes, ESR1 ≤10% expression is a required biomarker for enrollment.

Does this trial require PGR?

Yes, PGR ≤10% expression is a required biomarker for enrollment.

Does this trial require ERBB2?

Yes, ERBB2 negative is a required biomarker for enrollment.

What disease stage is eligible?

Stage IIA or IIB or IIIA or IIIB or IIIC is required.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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