Status:
UNKNOWN
Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
Lead Sponsor:
Shengjing Hospital
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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);
- able to undergo needle biopsy;
- voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Exclusion
- 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;
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05253066
Start Date
February 25 2022
End Date
January 31 2025
Last Update
February 23 2022
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