An Open, Multicenter, Randomized Controlled Clinical Study of Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer

Shengjing Hospital0 sites130 target enrollmentFebruary 25, 2022

InterventionsChidamide combined with exemestane (+/- goserelin)Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

DrugsChidamide combined with exemestane (+/- goserelin)Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Overview

Phase: Phase 2
Intervention: Chidamide combined with exemestane (+/- goserelin)
Conditions: Breast Neoplasms
Sponsor: Shengjing Hospital
Enrollment: 130
Primary Endpoint: ORR
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is an open, multicenter, randomized controlled clinical study aimed to explore the efficacy and safety of chidamide combined with exemestane (+/- goserelin) versus chemotherapy in the neoadjuvant treatment of stage II-III HR +/HER2- breast cancer patients with poor response to previous chemotherapy.

Registry

clinicaltrials.gov

Start Date

February 25, 2022

End Date

January 31, 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shengjing Hospital

Responsible Party

Principal Investigator

Caigang Liu

Director

Shengjing Hospital

Eligibility Criteria

Inclusion Criteria

•female patients aged greater than or equal to 18 years and less than or equal to 75 years, meet one of the following:
•previous oophorectomy, or age ≥ 60 years;
•age \< 60 years, natural postmenopausal status (defined as at least 12 consecutive months of spontaneous cessation of regular menstruation, and no other pathological or physiological causes), E2 and FSH in postmenopausal levels;
•premenopausal or perimenopausal female patients, must be willing to receive LHRH agonist therapy during the study;
•all patients were confirmed by histopathology as estrogen receptor (ER) positive (\> 10%), HER2 receptor negative.Follow the 2018 version of ASCO-CAP HER2-negative interpretation guideline criteria;
•tumor stage II-III meeting the AJCC 8th version criteria, patients who have previously received 2 cycles of TE regimen chemotherapy, with disease evaluation of SD or PD;
•KPS score ≥ 70 points;
•organ function level must meet the following requirements:
•bone marrow function ANC ≥ 1.5 × 109/L (14 without growth factors); PLT ≥ 100 × 109/L (7 without corrective treatment); Hb ≥ 100 g/L (7) without corrective treatment;
•liver and kidney function TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);

Exclusion Criteria

•received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
•received any other anti-tumor therapy at the same time;
•breast cancer, inflammatory breast cancer or occult breast cancer;
•stage IV breast cancer;
•breast cancer without histopathological diagnosis;

Arms & Interventions

Chidamide group

Chidamide combined with exemestane (+/- goserelin)

Intervention: Chidamide combined with exemestane (+/- goserelin)

chemotherapy group

Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Intervention: Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)

Outcomes

Primary Outcomes

ORR

Time Frame: Up to approximately 48 months

Secondary Outcomes

patient-reported outcome（PRO）：evaluate daily functioning and health outcomes from the patient's perspective by HRQOL(Up to approximately 48 months)
pCR：Upon completion of neoadjuvant therapy and surgery, there was no residual invasive carcinoma present in the pathologic assessment of the resected breast cancer samples stained with hematoxylin and eosin and all ipsilateral lymph node samples.(Up to approximately 48 months)
Breast-conserving rate(Up to approximately 48 months)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Up to approximately 48 months)
Total breast pathological complete remission rate (bpCR)(Up to approximately 48 months)
PEPI classification(Up to approximately 48 months)
Number of participants with treatment-related serious adverse event as assessed by CTCAE v5.0(Up to approximately 48 months)
Residual tumor burden (RCB) classification(Up to approximately 48 months)