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Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

StatusRecruiting
PhasePhase 2
Started2019-11-20
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 11, 2025 (before its estimated June 20, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-09-10
Study Status, Oversight v1
Primary completion date2022-06-20→2026-06-20
Completion date2022-09-20→2028-09-20
2019-11-07
Original filing
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.
Trial Details
NCT Number NCT04159142
Lead Sponsor Hebei Medical University Fourth Hospital
Collaborators: Beijing 302 Hospital, CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions Triple Negative Breast Cancer, Nab-paclitaxel
Enrollment 414 participants
Start Date 2019-11-20
Primary Completion 2026-06-20 (estimated)
Study Completion 2028-09-20 (estimated)
Updated on ClinicalTrials.gov 2025-09-11