RecruitingPhase 2NCT05475678

Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer

A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer

Sponsor

Zhenzhen Liu

Enrollment

369 participants

Start Date

Dec 20, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Triple-Negative Breast Cancer Camrelizumab

Summary

Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored. Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety. Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding camrelizumab (an immunotherapy drug) to a standard chemotherapy regimen (taxol plus carboplatin) before surgery can improve outcomes for women with triple-negative breast cancer — a type of breast cancer that tends to be more aggressive and harder to treat. **You may be eligible if...** - You are 18–70 years old and have been diagnosed with triple-negative breast cancer (a type that is ER-negative, PR-negative, and HER2-negative) - Your cancer is at least 2 cm in size (cT2 or larger) or involves the lymph nodes - You have not yet received any treatment for this cancer - Your heart function (ejection fraction ≥ 55%) and overall health are adequate **You may NOT be eligible if...** - Your cancer has already spread to distant parts of the body (metastatic) - You have already received chemotherapy, radiation, or targeted therapy for this cancer - You have a history of autoimmune disease or immunodeficiency - You have active hepatitis B or C, or severe heart or lung disease - You are pregnant or breastfeeding 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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