RecruitingPhase 2NCT06682195

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

Neoadjuvant Chemotherapy Combined With Toripalimab for Triple-negative Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST02)

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

35 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

TNBC - Triple-Negative Breast Cancer

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 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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding toripalimab (an immunotherapy drug) to standard chemotherapy before surgery (neoadjuvant treatment) improves outcomes for women with triple-negative breast cancer (TNBC) — an aggressive form that lacks the three common hormone receptors. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have confirmed triple-negative breast cancer with a tumor larger than 1 cm that has not spread to distant organs - You are in good physical health (ECOG 0–1) - Your PD-L1 expression has been tested **You may NOT be eligible if...** - You have stage IV (metastatic) breast cancer - You have serious heart, liver, or immune-related conditions - You are pregnant or planning to become pregnant during the study - You have already started chemotherapy 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.

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Interventions

DRUGNeoadjuvant chemotherapy combined with Toripalimab

1, Neoadjuvant Chemotherapy Phase Combined with Toripalimab 1. First Phase of Neoadjuvant Chemotherapy: Epirubicin + Cyclophosphamide + Toripalimab. Administered intravenously: 100 mg/m² Epirubicin + 600 mg/m² Cyclophosphamide + 240 mg Toripalimab, every 3 weeks for a total of 6 weeks. 2. Second Phase of Neoadjuvant Chemotherapy: Albumin-bound Paclitaxel + Toripalimab. Administered intravenously: 260 mg/m² Albumin-bound Paclitaxel + 240 mg Toripalimab, every 3 weeks for a total of 6 weeks. 2, Receive Breast Cancer Radical Surgery After 4 Cycles of Neoadjuvant Chemotherapy 3, Postoperative Adjuvant Therapy 1. If pathology indicates pCR: Continue immunotherapy, administering 240 mg Toripalimab intravenously every 3 weeks for a total of 1 year. 2. If pathology indicates non-PCR: Continue postoperative adjuvant chemotherapy combined with Toripalimab. 4, Perform Gene Testing on Biopsy Tissue Before Treatment, and Collect Blood Samples for ctDNA Testing Before and After Treatment.

Locations(13)

Nanchang People's Hospital

Nanchang, Jiangxi, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

The First Affiliated Hospital of Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Jinhua Municipal Central Hospital

Jinhua, China

Nantong First People's Hospital

Nantong, China

Zhongshan Hospital, Fudan University

Shanghai, China

Shanxi Provincial Cancer Hospital

Shanxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Xinjiang Medical University Affiliated Cancer Hospital

Xinjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT06682195

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