DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive 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 efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.

Eligibility criteria

Qualifiers

Voluntarily participate and sign the informed consent form;

Ages≥18 years;

Histopathologically confirmed invasive breast cancer, clinical stage T2-3 (tumor diameter > 2 cm), cN0- 3, M0;

Invasive breast tumour tissue confirmed HER2-positive by the central laboratory, defined as HER2 protein expression of IHC 3+ by immunohistochemistry (IHC) or IHC 2+ with amplification by in situ hybridisation (ISH) (according to the HER2 Guidelines for Breast Cancer, 2019 edition); and specimens from the primary site of the tumour for HER2 testing (wax blocks, sections or fresh tissue are acceptable) can be provided for HER2 testing;

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

Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs

Trial design

Treatments tested in this trial

  • Disitamab Vedotin Injection
  • Pertuzumab Injection
  • Toripalimab

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators