Clinical trial · Interventional
Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician) | Drug | — | UNRESOLVED |
| Chidamide combined with exemestane (+/- goserelin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chidamide group
- description
- Chidamide combined with exemestane (+/- goserelin)
- interventionNames
- Drug: Chidamide combined with exemestane (+/- goserelin)
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy group
- description
- Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
- interventionNames
- Drug: Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician)
Primary outcomes (1)
- measure
- ORR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available