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Brief Title: Clinical Study of Chidamide Combined With Chemotherapy in Neoadjuvant Treatment of HR+/ HER2-BC
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
Study ID: NCT05400993
Brief 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.
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 If the efficacy was SD+/PD, the study would be withdrawn Within 4 weeks after surgical treatment, the resected tumor tissue and lymph nodes were histopathologically examined (including the pathology of the tumor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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Cancer Hospital affiliated to Harbin Medical University, Haerbin, Heilongjiang, China
Bethune First Hospital of Jilin University, Changchun, Jilin, China
Health Science and Technology Information Center of Liaoning Health Industry Group Co., LTD, Benxi, Liaoning, China
Affiliated Zhongshan Hospital Dalian University, Dalian, Liaoning, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Liaoning Cancer Hospital, Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Name: Caigang Liu, doctoral
Affiliation: Shengjing Hospital
Role: PRINCIPAL_INVESTIGATOR