Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment o
This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur
| Condition(s) | Triple Negative Breast Cancer, Nab-paclitaxel |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy. |
| Who can participate | Inclusion Criteria: 1. Females with age between 18 to 70 years old; 2. Histologically confirmed triple negative breast cancer; 3. No more than one-line prior treatment for locally advanced or metastatic breast cancer; 4. Have at least one measurable lesion as per the RECIST criteria (version 1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one; 6. Patients with life expectancy of at least 3 months; 7. Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L); 8. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN; 9. Patients had good compliance with the planned treatment, |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Lead sponsor | Hebei Medical University Fourth Hospital |
| Locations | Shijiazhuang, Hebei, China |
| Start date | 2019-11-20 |
| NCT ID | NCT04159142 |
| Official listing | https://clinicaltrials.gov/study/NCT04159142 |