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

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 combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer

Eligibility criteria

Qualifiers

Voluntarily agree to participate in the study and sign the informed consent;

Age ≥18 years old (including the threshold value);

Histologically confirmed invasive breast cancer with clinical stage T1c-T2(≥2cm)cN1-2M0 or T3cN0-2M0;

As assessed by the research Center, the subjects can tolerate and plan to undergo radical surgery for breast cancer and have not previously received any anti-tumor systemic therapy for breast cancer;

Disqualifiers

Bilateral invasive breast cancer;

Previous history of invasive breast cancer;

Previously had carcinoma in situ of the breast and received adjuvant endocrine therapy within 5 years of surgery;

Use of the investigational drug or major surgery within 4 weeks prior to study dosing;

Trial design

Treatments tested in this trial

  • Disitamab Vedotin for Injection
  • Toripalimab
  • Epirubicin
  • Cyclophosphamide

Treatment groups

79 Participants
are divided into 1 treatment group

Sponsors and collaborators