Clinical Study of Chidamide Combined With Chemotherapy in Neoadjuvant Treatment of HR+/ HER2-BC

Breast Cancer Clinical Trial

Official title: A Multicenter, Single-arm Prospective Phase II Study of Chidamide in Combination With Chemotherapy for Neoadjuvant Treatment of HR-positive/HER2-negative Breast Cancer

Status Recruiting

Clinical Trial Summary

Neoadjuvant therapy for HR+/HER2- 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 patients.Basic 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 patients.In conclusion, we hypothesize that neoadjuvant therapy with chidamide combination therapy provides a better strategy for patients with HR + /HER2 - breast adenocarcinoma.

Clinical Trial 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 If the efficacy was SD+/PD, the study would be withdrawn Within 4 weeks after surgical treatment, the resected tumor tissue and lymph nodes were histopathologically examined (including the pathology of the tumor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 ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT05400993
• Study type: Interventional
• Source: Shengjing Hospital
• Contact: Caigang Liu, doctoral
• Phone: 18940264967
• Email: liucg@sj-hospital.org
• Status: Recruiting
• Phase: Phase 2
• Start date: May 23, 2022
• Completion date: May 23, 2024