Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
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 treatment of TNBC breast cancer with neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab , including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the event-free survival (EFS), Objective Response Rate(ORR), and radiologic complete response (rCR).

Eligibility criteria

Qualifiers

Female patients aged 18-70 years old;

ECOG score is 0-1 points;

Histologically confirmed stage II-III (T1N1-3; T2-4N0-2) invasive breast cancer;

ER-negative, PR-negative, and HER2 receptor-negative. Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is also classified as TNBC;

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 Sintilimab and Bevacizumab

Treatment groups

37 Participants
are divided into 1 treatment group