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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy combined with Toripalimab | Experimental | 1, Neoadjuvant Chemotherapy Phase Combined with Toripalimab
2, Receive Breast Cancer Radical Surgery After 4 Cycles of Neoadjuvant Chemotherapy 3, Postoperative Adjuvant Therapy
4, Perform Gene Testing on Biopsy Tissue Before Treatment, and Collect Blood Samples for ctDNA Testing Before and After Treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemotherapy combined with Toripalimab | Drug | 1, Neoadjuvant Chemotherapy Phase Combined with Toripalimab
2, Receive Breast Cancer Radical Surgery After 4 Cycles of Neoadjuvant Chemotherapy 3, Postoperative Adjuvant Therapy
4, Perform Gene Testing on Biopsy Tissue Before Treatment, and Collect Blood Samples for ctDNA Testing Before and After Treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response(PCR) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | 3 years | |
| radiologic complete response (rCR) | 3 years | |
| Objective Response Rate(ORR) |
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Inclusion Criteria:
Female patients aged 18-70 years old;
ECOG score is 0-1 points;
Histologically proven tumors >1cm in diameter (T1c-3; N0-2; M0) invasive breast cancer;
All patients had triple negative breast cancer confirmed by histopathology;
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.
The functional level of major organs must meet requirements
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.
Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhijun Dai | Contact | +86 157 0581 9132 | dzj0911@126.com | |
| Guansheng Zhong | Contact | +86 152 6817 7461 | guansheng@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanchang People's Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
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| 3 years |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | China |
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| The First Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | China |
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| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | China |
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| Jinhua Municipal Central Hospital | Recruiting | Jinhua | China |
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| Nantong First People's Hospital | Recruiting | Nantong | China |
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| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | China |
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| Shanxi Provincial Cancer Hospital | Not yet recruiting | Shanxi | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | China |
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| Xinjiang Medical University Affiliated Cancer Hospital | Not yet recruiting | Xinjiang | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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