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Chidamide Combined with Paclitaxel Liposome for the Treatment of Advanced HER2-negative Breast Cancer in Clinical Study

Ichrak Ben Abdallah (Beth Israel Deaconess Medical Center, Boston, MA)
Mehmet Sitki Copur (Riga Stradiņš University, Latvia)


The purpose of this study was to investigate the efficacy and safety of chidamide combined with paclitaxel liposome in the treatment of advanced HER-2-negative breast cancer. First, 41 patients with advanced HER-2-negative breast cancer who had received two chemotherapy regimens from May 2017 to November 2017 were randomly selected to receive chidamide combined with paclitaxel liposome treatment (observation group, n=20) or placebo combined with paclitaxel liposome treatment (control group, n=21). The treatment scheme of the observation group was oral chidamide 30mg twice a week for 2 months. In addition, on day 1, the patients were given paclitaxel liposome orally and intravenously administered with 175 mg/m2 for 1 cycle for 21 days and 3 cycles of chemotherapy. The treatment scheme of the control group was oral placebo 30 mg twice a week for 2 months. In addition, the method of paclitaxel liposome administration was the same as the observation group. The response rate (RR), disease control rate (DCR), and progression-free survival (PFS) were compared between the two groups. The results showed that all the 41 patients could be evaluated. In the observation group, CR5, PR7, SD5 and PD3 were obtained. RR was 60.0% and DCR was 85.0%. In the control group, CR3, PR3, SD5 and PD10 were obtained. RR was 28.6% and DCR was 52.4%. RR and DCR in the observation group were better than those in the control group, and the difference was statistically significant (P<0.05). The median PFS of the observation group was 5.2 months, longer than that of the control group (3.1 months, P<0.05). The main adverse reactions in the two groups were gastrointestinal reactions and bone marrow suppression, with grade 1~2 as the main ones. The incidence of leukopenia, thrombocytopenia and nausea and vomiting in the observation group was higher than that in the control group (P<0.05). Therefore, the chidamide combined with paclitaxel liposome is effective in the treatment of advanced HER-2-negative breast cancer, and the adverse reactions can be tolerated.


Breast cancer; Negative HER⁃2 expression; Chidamide; Paclitaxel liposomes.

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Copyright (c) 2020 Ichrak Ben Abdallah, Mehmet Sitki Copur

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