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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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.
Frequently asked questions
Is NCT06178159 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 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
What disease stage is eligible?
Stage CN0 or CN1 or CN2 or CN3 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages