Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC
We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.
| Condition(s) | Triple-negative Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy. |
| Who can participate | Inclusion Criteria: 1. Age: 18-65 years old; 2. Clinically and pathologically confirmed cT2- cT4d, or cT1c with axillary lymph node metastasis; 3. Three negative type and invasive breast cancer confirmed by histopathology; Three negative breast cancer is defined as: * ER and PR negative (IHC nuclear staining\<10%) * Her-2 negative (IHC 0, 1+without FISH, or IHC 2+without FISH amplification) 4. Clinically measurable lesions: Measurable lesions displayed by ultrasound, mammography, or MR (optional) within one month prior to screening; 5. Organ and bone marrow function tests within 2 weeks before chemotherapy indicate no contraindications for chemotherapy: * Absolute value of neutrophil count ≥ 2.0 × 109/L * Hemoglobin ≥ 100g/L * Platelet count ≥ 100 × 109/L * Total bilirubin\<1.5 ULN (upper |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Lead sponsor | Henan Cancer Hospital |
| Locations | Zhengzhou, Henan, China |
| Start date | 2024-11-06 |
| NCT ID | NCT06817525 |
| Official listing | https://clinicaltrials.gov/study/NCT06817525 |