A Phase 1/2 interventional study of Chidamide in Breast Cancer and Chemotherapy Effect, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 1/2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Also known as: Epidaza
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
Time frame: At 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
Plan to share: No — The individual data will not be made available in order to protect the participant's identity.
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences