Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRemeGen Co., Ltd.

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)

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators