Overview
Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-01-31
2025-01-31
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shengjing HospitalTreatments:
Docetaxel
Epirubicin
Exemestane
Goserelin
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:
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;