Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer. Participants with locally advanced (T1c-T2(≥2cm) N1-2M0 or T3-4cN0-2M0) HR-positive and HER2-negative breast cancer were enrolled to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with triplimab in the treatment of locally advanced HR-positive and HER2-negative breast cancer. About 30 participants are planned to participate in this clinical study.

Eligibility criteria

Qualifiers

Age 18-75 years old, gender is not limited;

Histologically or pathologically confirmed non-specific invasive ductal carcinoma, histologically grade3, ER≥1%, HER2 negative, Ki-67>20%;

T1c-T2(≥2cm)N1-2M0 or T3-4cN0-2M0;

No previous treatment;

Disqualifiers

Those who are known to be allergic to recombinant humanized antiPD-1 monoclonal antibody drugs and their components;

Currently participating in and receiving other research treatment;

Previously received systematic treatment for breast cancer, including systematic chemotherapy, targeted therapy, immunotherapy, etc.;

Remote metastatic lesions of breast cancer were confirmed by imaging or pathology;

Trial design

Treatments tested in this trial

  • TORIPALIMAB INJECTION(JS001 )
  • Stereotactic Body Radiation Therapy (SBRT)

Treatment groups

30 Participants
are divided into 1 treatment group