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.
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 If the efficacy was SD+/PD, the study would be withdrawn Within 4 weeks after surgical treatment, the resected tumor tissue and lymph nodes were histopathologically examined (including the pathology of the tumor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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Chidamide: take orally twice a week,4 tablets/time (20mg/ time), the interval between two doses should not be less than 3 days (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), the day before chemotherapy, 30 minutes after breakfast; Chidamide: 20mg, orally, twice a week, oral for two weeks and one week, a total of 8 cycles; Epirubicin 90mg/m2 , ivgtt, d1 Cyclophosphamide 600mg/m 2, ivgtt, d1 Q3w, 4 cycle; sequential Docetaxel 100 mg/m 2, IVGtt, D1 Q3w, 4 cycle。
Cancer Hospital affiliated to Harbin Medical University
Haerbin, Heilongjiang, China
RECRUITINGBethune First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGHealth Science and Technology Information Center of Liaoning Health Industry Group Co., LTD
Benxi, Liaoning, China
RECRUITINGAffiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, China
RECRUITINGShengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGLiaoning Cancer Hospital
Shenyang, Liaoning, China
RECRUITINGThe First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGRCB 0-1 points ratio
Residual tumor burden
Time frame: One month after surgery
pCR(ypT0/is、ypN0)
There was no residual tumor
Time frame: One month after surgery
bpCR(ypT0/is)
Breast pCRwith ypT0/is carcinoma in situ
Time frame: One month after surgery
ORR
Proportion of patients who had a 30% reduction in tumor volume and maintained it for more than four weeks
Time frame: Period of neoadjuvant therapy (treatment 1-6 months)
Breast retention rate
Percentage of patients with successful breast preservation
Time frame: One month after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.