RecruitingPhase 2NCT07351487

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

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


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

37 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy plus two immune-boosting drugs — sintilimab (an immunotherapy) and bevacizumab (an anti-blood vessel growth drug) — as a treatment given before surgery for triple-negative breast cancer (TNBC), a type of breast cancer that lacks common hormone and protein receptors. Researchers want to see if this combination can shrink tumors before surgery. **You may be eligible if:** - You are a female aged 18 to 70 - You have been diagnosed with stage II or III triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) - Your cancer is confirmed by biopsy - Your major organs are functioning adequately - You are willing to use effective contraception during and for at least 6 months after treatment **You may NOT be eligible if:** - Your cancer has spread to other parts of the body (stage IV) - You have inflammatory breast cancer - You have already received cancer treatment or radiation - You have serious heart problems, including heart failure or uncontrolled arrhythmia - You have active infections, HIV, or uncontrolled hepatitis B or C - You are pregnant or breastfeeding - You have had a severe immune-related reaction to prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNeoadjuvant 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07351487


Related Trials