OncoMatch/Clinical Trials/NCT06389006
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
Is NCT06389006 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Disitamab Vedotin for and Toripalimab for breast cancer.
Treatment: Disitamab Vedotin for · Toripalimab · Epirubicin · Cyclophosphamide — The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) low expression (IHC 1+ or IHC 2+, ISH negative) (IHC 1+ or IHC 2+, ISH negative)
low HER2 expression confirmed by the central laboratory is defined as IHC 1+ or IHC 2+ expression of HER2 protein detected by immunohistochemistry (IHC), and no amplification detected by in situ hybridization (ISH)
Required: ESR1 expression ≥ 1% (≥ 1%)
tumor tissue estrogen receptor (ER) ... expression ≥ 1%
Required: PR (PGR) expression ≥ 1% (≥ 1%)
tumor tissue ... progesterone receptor (PgR) expression ≥ 1%
Disease stage
Required: Stage T1C-T2(≥2CM)CN1-2M0, T3CN0-2M0 (clinical)
Grade: G3G2 (Nottingham grading system)
clinical stage T1c-T2(≥2cm)cN1-2M0 or T3cN0-2M0; Histological grade (Nottingham grading system) G3 or G2
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor systemic therapy
have not previously received any anti-tumor systemic therapy for breast cancer
Cannot have received: PD-(L)1, PD-L2, CTLA4 inhibitors and other Antibody-Drug Conjugates
Previous treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other Antibody-Drug Conjugates
Cannot have received: allogeneic hematopoietic stem cell transplantation or organ transplantation
Previous history of receiving allogeneic hematopoietic stem cell transplantation or organ transplantation
Cannot have received: adjuvant endocrine therapy
previously had carcinoma in situ of the breast and received adjuvant endocrine therapy within 5 years of surgery
Lab requirements
Blood counts
Hemoglobin ≥ 90g/L; ANC ≥1.5×10^9/L; Platelet ≥ 100×10^9/L
Kidney function
Serum creatinine ≤ 1.5x ULN or CrCl ≥ 50 mL/min
Liver function
Serum total bilirubin ≤ 1.5x ULN; AST and ALT ≤ 2.5x ULN
Cardiac function
NYHA Grade < 3; left ventricular ejection fraction ≥50%
Bone marrow or organ function ... Hemoglobin ≥ 90g/L; ANC ≥1.5×10^9/L; Platelet ≥ 100 ×10^9/L; Serum total bilirubin ≤ 1.5x ULN; AST and ALT ≤ 2.5x ULN; INR and aPTT ≤ 1.5x ULN; Serum creatinine ≤ 1.5x ULN or CrCl ≥ 50 mL/min; NYHA Grade < 3; left ventricular ejection fraction ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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