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OncoMatch/Clinical Trials/NCT05806060

Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

Is NCT05806060 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including VEGFR and TPC and TPC for triple-negative breast cancer.

Phase 3RecruitingFudan UniversityNCT05806060Data as of Jun 2026Location: China

Treatment: VEGFR and TPC · TPCThe study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC) in the first-line teatment of unresectable locally advanced or metastatic TNBC.

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Extracted eligibility criteria

Treatments studied

Other

VEGFR and TPCTPC

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) absence of expression

absence of HER2, ER, and PR expression

Required: ESR1 absence of expression

absence of HER2, ER, and PR expression

Required: PR (PGR) absence of expression

absence of HER2, ER, and PR expression

Disease stage

Required: Stage IV

Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection

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: chemotherapy

Exception: no previous chemotherapy for metastatic triple-negative breast cancer

Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer

Cannot have received: targeted therapy

Exception: no previous targeted therapy for metastatic triple-negative breast cancer

Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer

Lab requirements

Blood counts

The functions of major organs are basically normal

Kidney function

The functions of major organs are basically normal; Urine protein ≥2+ and 24h urine protein quantitative > 1.0 g [excluded]

Liver function

The functions of major organs are basically normal; Patients with known active HBV or HCV infection or hepatitis B DNA≥500, or chronic phase with abnormal liver function [excluded]

Cardiac function

Significant cardiovascular disease [excluded]

The functions of major organs are basically normal

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

Frequently asked questions

Is NCT05806060 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 absence of expression is a required biomarker for enrollment.

Does this trial require ESR1?

Yes, ESR1 absence of expression is a required biomarker for enrollment.

Does this trial require PGR?

Yes, PGR absence of expression is a required biomarker for enrollment.

What disease stage is eligible?

Stage IV 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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