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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747313
• Other study ID #: CSIIT-C39
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Qiao Li
• Phone: 15910573527
• Email: liqiaopumc[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Effect
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Chidamide
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.

Locations

Country	Name	City	State
China	National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital	Beijing	Beijing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	At 1 year
Secondary	Number of Patients With Clinical Responses (Phase I)	The number of patients with clinical responses (CR, VGPR, PR, or minimal response [MR]) will be summarized by stage.	Up to 1 year
Secondary	Overall Toxicity Rate	The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below by stage for Phase I patients.	Up to 1 year