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OncoMatch/Clinical Trials/NCT06851299

The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.

Is NCT06851299 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including trop2-ADC and ADC +anti-angiogenic drug for metastatic triple-negative breast cancer.

Phase 2RecruitingSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT06851299Data as of May 2026

Treatment: trop2-ADC · ADC +anti-angiogenic drug · ADC + PD1 monoclonal antibody +anti-angiogenic drugThis is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Disease stage

Metastatic disease required

Performance status

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

Prior therapy

Max 2 prior lines

Cannot have received: radiotherapy

receiving radiotherapy...within 4 weeks before enrollment

Cannot have received: chemotherapy

receiving...chemotherapy...within 4 weeks before enrollment

Cannot have received: endocrine therapy

receiving...endocrine therapy within 4 weeks before enrollment

Cannot have received: interventional drug clinical trial

participating in any interventional drug clinical trial

Lab requirements

Blood counts

WBC ≥3.0×10^9 / L, ANC ≥1.5×10^9 / L, PLT ≥70×10^9 / L

Kidney function

Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min

Liver function

Total bilirubin (TBIL) ≤3× ULN; ALT/AST ≤2.5×ULN (≤5xULN in patients with liver metastases)

Cardiac function

LVEF ≥ 55%, QTcF ≤ 470 ms

adequate bone marrow reserve: a. White blood cell count (WBC) ≥3.0×10^9 / L, b. Neutrophil count (ANC) ≥1.5×10^9 / L, c. Platelet count (PLT) ≥70×10^9 / L; liver, kidney and heart function tests were basically normal (according to the normal values of the laboratories in the study center) : a. Total bilirubin (TBIL) ≤3× ULN, b. ALT/AST ≤2.5×ULN (≤5xULN in patients with liver metastases), Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min; d. LVEF ≥ 55%, e. QTcF ≤ 470 ms.

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

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