OncoMatch/Clinical Trials/NCT04159142
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Is NCT04159142 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nab-paclitaxel + Carboplatin and Nab-paclitaxel + Capecitabine for triple negative breast cancer.
Treatment: Nab-paclitaxel + Carboplatin · Nab-paclitaxel + Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: capecitabine (capecitabine)
Exception: recurrence or metastasis within 6 months after capecitabine withdrawal
Recurrence or metastasis within 6 months after capecitabine withdrawal
Cannot have received: platinum-based chemotherapy
Exception: recurrence or metastasis within 6 months after platinum withdrawal
Recurrence or metastasis within 6 months after platinum withdrawal
Cannot have received: taxane (paclitaxel, albumin paclitaxel)
Exception: progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months
Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months
Lab requirements
Blood counts
neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L)
Kidney function
Serum creatinine≤ 1.5×institutional upper limit of normal (ULN)
Liver function
AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN
Cardiac function
Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores [excluded]
Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L); 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; Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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