Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer

A Prospective, Single-arm, Open-lable, Single-center Phase Ib/II Clinical Study of Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer

The mechanism of action of cidabenamide and the advantages of vincristine metronomic chemotherapy make it possible to combine the two drugs. Therefore, it is necessary to conduct a prospective study to investigate the value of chidamide in combination with vincristine metronomic treatment for triple-negative breast cancer.

The mechanism of action of cidabenamide and the advantages of vincristine metronomic chemotherapy make it possible to combine the two drugs. Therefore, it is necessary to conduct a prospective study to investigate the value of chidamide in combination with vincristine metronomic treatment for triple-negative breast cancer.The current study was designed to explore the efficacy of oral two-metronomic agents (chidamide in combination with vincristine) in advanced triple-negative patient in China.

Inclusion Criteria:

• female;
• aged ≥ 18 years and ≤75 years;
• histologically proved metastatic triple-negative breast cancer;
• at least one measurable or evaluable lesion based on RECIST 1.1 criteria;
• estimated life expectancy ≥ 3 months; (6) normal heart, liver, and kidney function;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; -
• informed consent signed by the participants.

Exclusion Criteria:

• received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation;
• participated in other new drug clinical trials within 4 weeks before enrollment;
• inflammatory breast cancer;
• symptomatic visceral disease;
• second primary malignancy;
• mental disorder.