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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 (Jun 2026). This Phase 3 trial studies multiple treatments including Antivascular therapy and Chemotherapy for breast cancer.

Phase 3RecruitingFudan UniversityNCT05909332Data as of Jun 2026Location: China

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

Treatments studied

Other

Antivascular therapyChemotherapy

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)

Demographics

Ages ≤ 70
Female only

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.

Frequently asked questions

Is NCT05909332 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 ERBB2?

Yes, ERBB2 negative is a required biomarker for enrollment.

Does this trial require ESR1?

Yes, ESR1 negative is a required biomarker for enrollment.

Does this trial require PGR?

Yes, PGR 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 there an age limit?

Yes. Patients must be 70 years or younger.

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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