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OncoMatch/Clinical Trials/NCT05909332

Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)

Is NCT05909332 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Antivascular therapy and Chemotherapy for breast cancer.

Phase 3RecruitingFudan UniversityNCT05909332Data as of May 2026

Treatment: Antivascular therapy · ChemotherapyThis is a randomized, open-label phase III clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/Immune suppressed subtype.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Biomarker criteria

Required: HER2 (ERBB2) negative (negative)

Required: ESR1 negative (negative)

Required: PR (PGR) negative (negative)

Disease stage

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

Excluded: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: neoadjuvant therapy

Has received neoadjuvant therapy (including chemotherapy, targeted therapy, and radiotherapy)

Lab requirements

Blood counts

ANC ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Platelet count ≥ 75×10^9/L (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 2 weeks before day 1 of course 1)

Kidney function

serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula)

Liver function

AST, ALT, and alkaline phosphatase ≤ 3 × ULN; serum total bilirubin ≤ 1.0 × ULN

Cardiac function

left ventricular ejection fraction (LVEF) < 50% (a cardiac ultrasound) [excluded]

Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Platelet count ≥ 75×10^9/L (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 2 weeks before day 1 of course 1); AST, ALT, and alkaline phosphatase ≤ 3 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula); left ventricular ejection fraction (LVEF) < 50% (a cardiac ultrasound) [excluded]

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

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