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

January 13, 2026 updated by: First Affiliated Hospital of Zhejiang University

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Yang Yu
      • Hangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
        • Contact:
          • Heming Zheng
      • Harbin, China
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Tong Liu
      • Hefei, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Ying Chen
      • Jinhua, China
        • Recruiting
        • Jinhua Municipal Central Hospital
        • Contact:
          • Chaoyang Xu
      • Nantong, China
        • Recruiting
        • Nantong First People's Hospital
        • Contact:
          • Jian Qiu
      • Shanghai, China
        • Recruiting
        • Zhongshan hospital, Fudan university
        • Contact:
          • Wei Zhu
      • Shanxi, China
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
          • Xiaomin Yang
      • Xi'an, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Huafeng Kang
      • Xinjiang, China
        • Not yet recruiting
        • Xinjiang Medical University Affiliated Cancer Hospital
        • Contact:
          • Hongtao Li
      • Zhengzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Pengwei Lv
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • Nanchang People's Hospital
        • Contact:
          • Yili Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients aged 18-70 years old;
  2. ECOG score is 0-1 points;
  3. Histologically proven tumors >1cm in diameter (T1c-3; N0-2; M0) invasive breast cancer;
  4. All patients had triple negative breast cancer confirmed by histopathology;

  5. Pathological examination of PD-L1 expression:

    The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our center detected the PD-L1 antibody site as 22C3.

  6. The functional level of major organs must meet requirements
  7. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.
  8. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.

Exclusion Criteria:

  1. Stage IV breast cancer.
  2. Inflammatory breast cancer.
  3. 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.
  4. 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.
  5. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.
  6. Serious heart disease or discomfort, including but not limited to the following diseases:

1) Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%).2) High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block).3) Angina requiring medication for treatment. 4) Heart valve disease with clinical significance. 5) ECG shows transmural myocardial infarction. 6) Poor control of hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 180mmHg after drug treatment) 100mmHg).

7. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

8. Patients with chronic active hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, stable hepatitis B after drug treatment [HBV-DNA test negative or<50IU/ml] and cured hepatitis C patients [HCV RNA test negative]).

9. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication.

10. Individuals with a known history of allergies to the components of this medication regimen.

11. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 6 months after the last study medication.

12. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant 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.
Drug: Neoadjuvant 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathologic complete response（PCR）
Time Frame: 2 years
The primary study objective is to evaluate the pathologic complete response（PCR） of Neodjuvant treatment of TNBC breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Event-free survival (EFS)
Time Frame: 3 years
3 years
Objective Response Rate(ORR)
Time Frame: 3 years
3 years
radiologic complete response (rCR)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20240127C-R2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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