OncoMatch/Clinical Trials/NCT06227117
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
Is NCT06227117 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: Disitamab Vedotin · Toripalimab （18weeks） · Carboplatin · Disitamab Vedotin · Sequential Epirubicin · Sequential CTX · Toripalimab （12weeks） — The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (ER <1% by IHC) (<1% ER nuclear staining by IHC)
Tumour hormone receptor (HR)-negative, defined as IHC-stained invasive carcinoma with a proportion of cells positive for both ER and PgR nuclear staining of <1% according to ASCO/CAP guideline 2020
Required: PR (PGR) negative (PgR <1% by IHC) (<1% PgR nuclear staining by IHC)
Tumour hormone receptor (HR)-negative, defined as IHC-stained invasive carcinoma with a proportion of cells positive for both ER and PgR nuclear staining of <1% according to ASCO/CAP guideline 2020
Required: HER2 (ERBB2) low expression (IHC 1+ or IHC 2+ with no amplification by ISH) (IHC 1+ or IHC 2+ with no amplification by ISH)
low HER2 expression confirmed by the central laboratory, defined as HER2 protein expression of IHC 1+ or IHC 2+ with no amplification by in situ hybridisation (ISH)
Disease stage
Required: Stage T1CN1-2M0, T2-3N0-2M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumour systemic therapy
have not received any prior anti-tumour systemic therapy for breast cancer
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: investigational drugs
Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration
Cannot have received: adjuvant endocrine therapy
Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years of surgery
Lab requirements
Blood counts
haemoglobin ≥ 90 g/L; ANC ≥ 1.5 × 10^9 /L; platelets ≥ 100 × 10^9 /L
Kidney function
Creatinine Clearance (CrCl) ≥ 60 mL/min according to the Cockcroft-Gault formula method
Liver function
serum total bilirubin ≤ 1.5x ULN; AST and ALT ≤ 2.5x 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%; ...haemoglobin ≥ 90 g/L; ANC ≥ 1.5 × 10^9 /L; platelets ≥ 100 × 10^9 /L; serum total bilirubin ≤ 1.5x ULN; AST and ALT ≤ 2.5x ULN; INR and aPTT ≤ 1.5x ULN; CrCl ≥ 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06227117 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 ESR1?
Yes, ESR1 negative (ER <1% by IHC) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative (PgR <1% by IHC) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 low expression (IHC 1+ or IHC 2+ with no amplification by ISH) is a required biomarker for enrollment.
What disease stage is eligible?
Stage T1CN1-2M0 or T2-3N0-2M0 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 qualifyRelated pages