Clinical Trials List
2016-12-29 - 2023-09-28
Phase III
Recruiting6
Terminated2
ICD-10C50
Malignant neoplasm of breast
ICD-10C79.81
Secondary malignant neoplasm of breast
ICD-9174.0
Malignant neoplasm of female breast, nipple and areola
A Phase III Trial of Chidamide in Combination with Exemestane in Patients with Hormone Receptor-Positive Advanced Breast Cancer (ACE)
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Trial Applicant
GNT Biotech & Medicals Corporation,
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- CHIN-SHENG HUNG Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-Wen Chang Division of General Surgery
- 方嘉郎 Division of Others
- Mao-Chih Hsieh Division of General Surgery
- Chia-Lun Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Yao-Yu Hsieh Division of Hematology & Oncology
- Wei-Hong Cheng Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
- Tsu-Yi Chao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
11 Recruiting
Audit
None
Co-Principal Investigator
- Chen-Teng Wu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
- Yao-Chung Wu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 甘蓉瑜 Division of General Surgery
- Ming-Feng Hou Division of General Surgery
- Junping Shiau Shiau Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Secondary Endpoints:
Overall Survival (OS)
Duration of Response (DOR)
Objective Response Rate (ORR)
Clinical Benefit Response (CBR, CR + PR + SD ≥ 24 weeks)
2、Safety Endpoints
Safety is assessed by evaluating frequency and severity of adverse events, vital signs and changes in laboratory variables. The severity of AE will be judged according to CTCAE v4.0 criteria
Inclution Criteria
1) 20~ 75 years old, postmenopausal women;
2) Histological or cytological confirmation of hormone receptorpositive [estrogen eceptor (ER) positive] breast cancer;
3) Disease progression or recurrence after at least one endocrine therapy (either in advanced/metastatic setting or adjuvant setting);
4) ≤4 prior therapies (either in advanced/metastatic setting or adjuvant setting), patients may have received one prior chemotherapy;
5) The disease condition is inoperable, stage III or stage IV, at least one measurable lesion or simple bone metastases with no measurable lesions;
6) Last prior therapy intervals: (a) if the last treatment was endocrine therapy, the interval must ≥ 2 weeks; (b) if the last treatment was chemotherapy therapy, the interval must ≥ 4 weeks;
7) Eastern Cooperative Oncology Group Performance Status: 0 ~ 1;
8) Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 /L, hemoglobin ≥ 90 g/L;
9) Life expectancy ≥ 3 months;
10) Written informed consent obtained before any trial related activity and according to local guidelines.
Exclusion Criteria
2) Patients with human epidermal growth factor receptor-2 (Her-2) positive;
3) Patients previously received treatment with exemestane;
4) Patients received radiotherapy ≤ 4 weeks prior to study entry;
5) Patients with no measurable lesion (except simple bone metastasis), such as pleural or pericardial effusion, ascites, etc.;
6) Patients have uncontrolled or significant cardiovascular disease, including:
a. Myocardial infarction (< the last 12 months)
b. Uncontrolled angina (< the last 6 months)
c. Congestive heart failure (< the last 6 months), or Left
Ventricular Ejection Fraction (LVEF) < 50% prior to study entry
d. History of any significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or TdP)
e. History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 450 ms prior to study entry
f. History of cerebrovascular accident
g. Symptomatic coronary heart disease requiring treatment with agents
7) Patients with visceral crisis;
8) The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm;
9) History of organ transplantation;
10) Patients have not recovered from all clinically relevant toxicities to grade 1 due to prior therapies;
11) Patients have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would interfere the ingestion, transportation or absorption of oral agents;
12) Active infection [suffered from active infection of bacteria, virus, fungi, mycobacteria, parasites, or other infections (excluding nail bed fungal infections), or require ntravenous antibiotic therapy, or antiviral therapy, or hospitalization due to any significant infection events within 4 weeks], or persistent fever within 14 days prior to
study entry;
13) Patients had organ surgery < 6 weeks prior to study entry;
14) Abnormal liver function [total bilirubin > 1.5 times upper limit of normal (> 3 times upper limit of normal in case of Gilbert syndrome); Transaminases (ALT, AST) >2.5 times upper limit of normal (>5 times upper limit of normal patients with liver metastases), abnormal renal function (serum creatinine > 1.5 times upper limit of normal);
15) Patients with prior invasive malignancies with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, unless received curative treatment and with documented evidence of no recurrence in the past five years;
16) Any mental or cognitive disorder, that would interfere the ability to understand the informed consent document or the operation and compliance of study;
17) Patients are currently enrolled in another investigational drug study, or completed within 4 weeks prior to study entry, with the exception of patients only in overall survival follow-up;
18) Any other condition which is inappropriate for the study in the opinion of the investigators
The Estimated Number of Participants
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Taiwan
55 participants
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Global
420 participants
