About this trial
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
Eligibility criteria
Qualifiers
Voluntarily participate and sign the informed consent form;
Ages≥18 years;
Invasive breast tumour tissue with 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) (according to the Breast Cancer HER2 Detection Guidelines, 2019 edition) by immunohistochemistry; and specimens from the primary site of the tumour for HER2 detection (wax blocks, biopsies, or fresh tissues are acceptable) are available for HER2 detection
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;
Disqualifiers
With bilateral invasive breast cancer
Previous history of invasive breast cancer
Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years of surgery
Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration
Trial design
Treatments tested in this trial
- Disitamab Vedotin Injection (18 weeks)
- Toripalimab (18weeks)
- Carboplatin
- Disitamab Vedotin Injection (12 weeks)
- Sequential Epirubicin
- Sequential CTX
- Toripalimab (12weeks)