OncoMatch/Clinical Trials/NCT06178159
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
Is NCT06178159 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Disitamab Vedotin and Pertuzumab for breast cancer.
Treatment: Disitamab Vedotin · Pertuzumab · Toripalimab — The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
HER2 protein expression of IHC 3+ by immunohistochemistry (IHC)
Required: HER2 (ERBB2) amplification (IHC 2+ with amplification by ISH)
IHC 2+ with amplification by in situ hybridisation (ISH)
Disease stage
Required: Stage CN0, CN1, CN2, CN3
Performance status
NYHA 0–2
Prior therapy
Cannot have received: PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs
Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs
Cannot have received: anti-HER2 therapy
Prior anti-HER2 therapy including but not limited to ADC
Lab requirements
Blood counts
haemoglobin ≥ 90 g/L; absolute neutrophil count (ANC) ≥ 1.5 × 10^9 /L; platelets ≥ 100 × 10^9 /L
Kidney function
Creatinine Clearance (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula method
Liver function
serum total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN
Cardiac function
NYHA class <3; left ventricular ejection fraction ≥55%
Cardiac function: New York Heart Association (NYHA) class <3; left ventricular ejection fraction ≥55%; Bone marrow or organ function, the following criteria should be met within 7 days prior to study dosing: haemoglobin ≥ 90 g/L; absolute neutrophil count (ANC) ≥ 1.5 × 10^9 /L; platelets ≥ 100 × 10^9 /L; serum total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; INR and APTT ≤ 1.5 × ULN; Creatinine Clearance (CrCl) ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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