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

Launched by ZHENZHEN LIU · Jul 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with triple-negative breast cancer (TNBC), which is a more aggressive form of breast cancer that does not respond to some common therapies. The study is looking at the effectiveness of a drug called camrelizumab, combined with a chemotherapy regimen (TCb), compared to the TCb regimen alone. The goal is to see if this combination can provide better and safer treatment options for women before surgery, particularly for those with cancer that has spread to the lymph nodes.

To participate in the trial, women aged 18 to 70 with a confirmed diagnosis of TNBC and measurable tumors may be eligible. Key requirements include having certain test results that show their heart and organ functions are healthy and not having received prior treatments for this cancer. If you decide to participate, you'll receive treatment and be closely monitored for how well it works and any side effects. This trial aims to help improve outcomes for women battling this challenging form of breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18-70 years old
• • 2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
• 3. Pathologically proven triple negative breast cancer:
• Triple-negative breast cancer is defined as:
• • Negative for ER and PR (IHC nuclear staining \<10%)
• • Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
• • 4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
• • 5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
• • 6. Cardiac ultrasound EF value ≧55%；
• • 7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
• • 8. ECOG score≤1 point;
• • 9. Sign informed consent；
• Exclusion Criteria:
• • 1. The patient has evidence of metastatic breast cancer；
• • 2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
• • 3. The patient has a second primary malignancy other than adequately treated skin cancer;
• • 4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
• • 5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
• • 6. The patient has severe lung or heart disease;
• • 7. The patient has active hepatitis B and C;
• • 8. The patient has a history of organ transplantation or bone marrow transplantation;
• • 9. pregnant or breastfeeding women;
• • 10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.