The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Location status: Recruiting
NCT Number: NCT04159142
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.
Interested in participating?
Request Info18 year–70 year
Female
Interventional
Phase 2
Shijiazhuang, Hebei, 050011, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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;
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;
Time frame: 3 years
Up to disease progression or death due to any cause
Time frame: At the end of Cycle 6 (each cycle is 21 days)
From the date of randomization to the end of 6 cycles
Time frame: 3 years
To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer
Time frame: 3 years
To evaluate the overall survival of patients with advanced triple-negative breast cancer
Time frame: 3 years
To evaluate the adverse events of patients with advanced triple-negative breast cancer
Contact information is provided by the study sponsor or research team.
Hebei Medical University Fourth Hospital
Other
Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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