Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer

China Medical University

Status and phase

Not yet enrolling

Phase 3

Phase 2

Conditions

Breast Neoplasms

Treatments

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

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05253066

MUKDEN5

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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:
1. previous oophorectomy, or age ≥ 60 years;
2. 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;
3. 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:
1. 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;
2. 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);
able to undergo needle biopsy;
voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up

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;