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RECRUITING
NCT07351487
PHASE2

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

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

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).

Official title: Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for Triple Negative Breast Cancer:A Prospective, Single-Arm, Multicenter Clinical Study (NEOTORCII-BREASTO7)

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2025-09-25

Completion Date

2030-09-25

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (2)

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Zhongshan Hospital, Fudan University

Shanghai, China