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

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT07351487
Phase
PHASE2
Status
Recruiting
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Conditions

  • TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab — DRUG
    1, Neoadjuvant Chemotherapy Phase Combined with Sintilimab and Bevacizuma, Administered intravenously: carboplatin (AUC=5), nab-paclitaxel (260 mg/m²) + 200 mg Sintilimab + Bevacizumab (7.5 mg/kg), every 3 weeks for a total of 12 weeks. 2, Receive Breast Cancer Definitive Surgery After 4 Cycles of Neoadjuvant Chemotherapy 3, Postoperative Adjuvant Therapy 1)If pathology indicates pCR: Continue immunotherapy, administering 200 mg Sintilimab intravenously every 3 weeks for a total of 1 year. 2)If pathology indicates non-PCR: Continue 4 cycles of postoperative adjuvant chemotherapy (100 mg/m² Epirubicin + 600 mg/m² Cyclophosphamide) combined with 200 mg Sintilimab intravenously every 3 weeks for a total of 1 year. 4, Perform Gene Testing on Biopsy Tissue Before Treatment, and Collect Blood Samples for ctDNA Testing Before and After Treatment.

Study Details

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).

Key Dates

First listed
Jan 20, 2026
Start date
Sep 25, 2025
Status verified
Sep 2025
Primary completion
Sep 25, 2028
Completion
Sep 25, 2030

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab
    1, Neoadjuvant Chemotherapy Phase Combined with Sintilimab and Bevacizuma, Administered intravenously: carboplatin (AUC=5), nab-paclitaxel (260 mg/m²) + 200 mg Sintilimab + Bevacizumab (7.5 mg/kg), every 3 weeks for a total of 12 weeks. 2, Receive Breast Cancer Definitive Surgery After 4 Cycles of Neoadjuvant Chemotherapy 3, Postoperative Adjuvant Therapy 1)If pathology indicates pCR: Continue immunotherapy, administering 200 mg Sintilimab intravenously every 3 weeks for a total of 1 year. 2)If pathology indicates non-PCR: Continue 4 cycles of postoperative adjuvant chemotherapy (100 mg/m² Epirubicin + 600 mg/m² Cyclophosphamide) combined with 200 mg Sintilimab intravenously every 3 weeks for a total of 1 year. 4, Perform Gene Testing on Biopsy Tissue Before Treatment, and Collect Blood Samples for ctDNA Testing Before and After Treatment.

Primary Outcome Measure

pathologic complete response（PCR） [ Time Frame: 3 years ]

Central Contacts

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