A Phase 2 interventional study of Nab-paclitaxel + Carboplatin and Nab-paclitaxel + Capecitabine in Triple Negative Breast Cancer and Nab-paclitaxel, sponsored by Hebei Medical University Fourth Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Hebei Medical University Fourth Hospital · Phase 2, Interventional, and Treatment
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.
1,139 studies on the registry are indexed under Triple Negative Breast Neoplasms; 442 are open to participants now.
This study's planned enrollment of 414 is above the median of 61 across 981 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Hebei Medical University Fourth Hospital is the lead sponsor of 78 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m\^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;
Drug: Nab-paclitaxel + Carboplatin
Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m\^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;
Drug: Nab-paclitaxel + Capecitabine
nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；
Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles；
Progression free survival (PFS)
Up to disease progression or death due to any cause
Time frame: 3 years
PFS rate for 6 cycles
From the date of randomization to the end of 6 cycles
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Objective response rate (ORR)
To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer
Time frame: 3 years
Overall survival (OS)
To evaluate the overall survival of patients with advanced triple-negative breast cancer
Time frame: 3 years
Adverse events (AE)
To evaluate the adverse events of patients with advanced triple-negative breast cancer
Time frame: 3 years
Plan to share: Undecided
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Hebei Medical University Fourth Hospital