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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
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.
Frequently asked questions
Is NCT06389006 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 low expression (IHC 1+ or IHC 2+, ISH negative) is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression ≥ 1% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression ≥ 1% is a required biomarker for enrollment.
What disease stage is eligible?
Stage T1C-T2(≥2CM)CN1-2M0 or T3CN0-2M0 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 qualify