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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Criteria

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.