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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Chemotherapy Effect; Breast Cancer

Treatments: Drug: Chidamide

Study type: Interventional

Funder types: Other

Identifiers

NCT05747313

CSIIT-C39

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Study group

Experimental group

Description:

Phase Ib: The dose of vincristine administered in this phase is 40 mg on days 1,3,5 of each cycle. The timepoint for chidamide dosing in this phase is twice weekly, i.e., dosing on days 1,4,8,11,15,18 of each cycle. Take 30 minutes after a meal. Phase II: This phase is based on the MTD/RP2D determined in phase I. The phase II expansion group study was conducted. Vincristine is administered at a dose of 40 mg on days 1,3,5 of each cycle. Chidamide was administered at a dose of MTD/RP2D twice a week on days 1,4,8,11,15 and 18 of each cycle. It is to be taken 30 minutes after a meal.

Treatment:

Drug: Chidamide