Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05400993
Status:
UNKNOWN
Last Update Posted:
2022-06-06
First Post:
2022-05-27
Brief Title:
Clinical Study of Chidamide Combined With Chemotherapy in Neoadjuvant Treatment of HR HER2-BC
Sponsor:
Shengjing Hospital
Organization:
Shengjing Hospital
Study Overview
Official Title:
A Multicenter Single-arm Prospective Phase II Study of Chidamide in Combination With Chemotherapy for Neoadjuvant Treatment of HR-positiveHER2-negative Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neoadjuvant therapy for HRHER2- breast cancer is dominated by anthracycline combined with paclitaxel chemotherapy Aggressive neoadjuvant chemotherapy can only achieve pCR in about 10 of PATIENTS with HR-positive breast cancer The emergence of new targeted drugs brings new life and hope to HR-positive breast cancer patientsBasic studies have shown that the abnormal state of epigenetics is associated with the metastasis of drug resistance and recurrence of tumor histone deacetylase HDAC is an important regulator of epigenetic regulation and drugs targeting HDAC provide a new strategy for tumor therapy The ACE study suggests that selective HDAC inhibitor chidamide in combination with endocrine therapy significantly improves survival benefit in patients with hr-positive HER2-negative advanced breast cancer who relapsed or progressed after endocrine therapy providing a new treatment option for these patientsIn conclusion we hypothesize that neoadjuvant therapy with chidamide combination therapy provides a better strategy for patients with HR HER2 - breast adenocarcinoma
Detailed Description:
A total of 59 patients with stage Ii-III HR HER2 - breast cancer were enrolled in a multi-center single-arm prospective design The main purpose of the study was to observe the efficacy and safety of chidamide combined with chemotherapy in neoadjuvant treatment of stage II-III HR HER2 - breast cancer Breast MRI and other imaging examinations were reviewed every 2 cycles to evaluate the efficacy If the efficacy was accurate surgical treatment was performed within 4 weeks after the 8th cycle of neoadjuvant therapy If the efficacy was SDPD the study would be withdrawn Within 4 weeks after surgical treatment the resected tumor tissue and lymph nodes were histopathologically examined including the pathology of the tumor resection margin The pathological sections were uniformly lent to the master research unit for unified review
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None