Clinical trial NCT05747313: Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Chemotherapy Effect
Keywords: Breast Cancer
metronomic treatment
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The experiment was a single-arm study design. The study is divided into two phases.

Phase I : single-arm, open, dose-climbing Phase Ib clinical study to determine the safety and tolerability of the combination regimen and to define the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or recommended dose for Phase II studies of this combination regimen.

Phase II : Single-arm, open, single-center Phase II clinical study to assess the efficacy and safety of the recommended dose administered in Phase II.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: At 1 year
Secondary outcomes:
measure: Number of Patients With Clinical Responses (Phase I)
timeFrame: Up to 1 year
measure: Overall Toxicity Rate
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
state: Beijing
Study officials:
affiliation: National Cancer Center/National Clinical Research Center for Cancer
name: Binghe Xu
role: STUDY_DIRECTOR
References: