Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response(PCR) of Adjuvant treatment of TNBC breast cancer with Toripalimab combined with neoadjuvant chemotherapy, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)

Eligibility criteria

Qualifiers

Female patients aged 18-70 years old;

ECOG score is 0-1 points;

Histologically proven tumors >1cm in diameter (T1c-3; N0-2; M0) invasive breast cancer;

All patients had triple negative breast cancer confirmed by histopathology;

Disqualifiers

Stage IV breast cancer.

Inflammatory breast cancer.

Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.

Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.

Trial design

Treatments tested in this trial

  • Neoadjuvant chemotherapy combined with Toripalimab

Treatment groups

35 Participants
are divided into 1 treatment group