Clinical Trials List
Protocol NumberEGC002
NCT Number(ClinicalTrials.gov Identfier)NCT03072238
Completed
2018-05-02 - 2022-01-20
Phase III
Recruiting6
ICD-10C50
Malignant neoplasm of breast
A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 (EirGenix Trastuzumab) with HerceptinR as Neoadjuvant Treatment in Combination with Anthracycline/Paclitaxel-based Systemic Therapy in Patients with HER2-positive Early Breast Cancer
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Trial Applicant
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED
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Sponsor
EIRGENIX, INC.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/15
Investigators and Locations
Co-Principal Investigator
- 郭文宏 Division of General Surgery
- MING-YANG WANG Division of General Surgery
- YEN-SHEN LU Division of General Surgery
- 林季宏 Division of General Surgery
- 張端瑩 Division of General Surgery
- Wei-Wu Chen Division of General Surgery
- 羅喬 Division of General Surgery
- 蔡立威 Division of General Surgery
- 林柏翰 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 金光亮 Division of General Surgery
- 邱仁輝 Division of General Surgery
- Yi-Fang Tsai Division of General Surgery
- 林燕淑 Division of General Surgery
- Ta-Chung Chao Division of General Surgery
- Chun-Yu Liu Division of General Surgery
- 賴亦貞 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 黃子權 Division of Hematology & Oncology
- 吳宜穎 Division of Hematology & Oncology
- 陳佳宏 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
- 俞志誠 Division of Hematology & Oncology
- 廖國秀 Division of Hematology & Oncology
- 洪志杰 Division of Hematology & Oncology
- 于承平 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Ming-Feng Hou Division of General Surgery
- 甘蓉瑜 Division of General Surgery
- 巫承哲 Division of General Surgery
- Junping Shiau Shiau Division of General Surgery
- Fu Ouyang Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HWEI-CHUNG WANG Division of General Surgery
- 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
Co-Principal Investigator
Audit
None
Co-Principal Investigator
Principal Investigator
Shin-Cheh Chen
Linkou Chang Gung Medical Foundation
Taiwan National PI
陳訓徹
Co-Principal Investigator
- 沈士哲 Division of General Surgery
- Wen-Ling Kuo Division of General Surgery
- Chi-Chang Yu Division of General Surgery
- 周旭桓 Division of General Surgery
- Yung-Chang Lin Division of General Surgery
- Wen-Chi Shen Division of General Surgery
The Actual Total Number of Participants Enrolled
1 Recruiting
Audit
None
Condition/Disease
Metastatic Prostate Cancer
Objectives
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
Test Drug
EG12014
Active Ingredient
Trastuzumab
Dosage Form
Powder for Solution
Dosage
mg
Endpoints
Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population rPFS was defined as time from date of randomization to the first occurrence of documented disease progression (PD), as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm) in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The Kaplan-Meier (KM) estimate was used to determine the median rPFS. Up to approximately 32 months
Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to RECIST v1.1 criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The KM estimate was used to determine the median rPFS. Up to approximately 32 months
Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to RECIST v1.1 criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The KM estimate was used to determine the median rPFS. Up to approximately 32 months
Inclution Criteria
Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1 at screening
Adequate hematologic and organ function within 28 days before the first study treatment
Ability to comply with the study protocol, in the investigator's judgment
Willingness and ability of participants to use the electronic device to report selected study outcomes; Caregivers and site staff can assist with patient diary input but patient must be able to independently comprehend and answer the questionnaires
Life expectancy of at least 6 months
Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
For enrollment into the China extension cohort, residence in the People's Republic of China
Disease-specific Inclusion Criteria:
Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) or a minimum of 15 (20 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report (with tumor content information, Gleason score, and disease staging) for PTEN IHC and NGS testing and for other protocol-mandated secondary and exploratory assessments. If only 12-14 slides are available, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor. Cytologic or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases is not acceptable
A valid PTEN IHC result (testingcentral laboratory tested with results directly sent to IxRS) (e.g., participants with an "invalid" or "failed" PTEN IHC result are not permitted to enroll)
Metastatic disease documented prior to randomization by clear evidence of bone lesions on bone scan and/or measurable soft tissue disease by computed tomography (CT) and/or magnetic resonance imaging (MRI) (at least one target lesion) according to RECIST v1.1
Asymptomatic or mildly symptomatic form of prostate cancer
Progressive disease before initiating study treatment
Ongoing androgen deprivation with gonadotropin-releasing hormone (GnRH) analog or bilateral orchiectomy, with serum testosterone <= 50 ng/dL (<= 1.7 nmol/L) within 28 days before randomization
Adequate hematologic and organ function within 28 days before the first study treatment
Ability to comply with the study protocol, in the investigator's judgment
Willingness and ability of participants to use the electronic device to report selected study outcomes; Caregivers and site staff can assist with patient diary input but patient must be able to independently comprehend and answer the questionnaires
Life expectancy of at least 6 months
Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
For enrollment into the China extension cohort, residence in the People's Republic of China
Disease-specific Inclusion Criteria:
Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) or a minimum of 15 (20 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report (with tumor content information, Gleason score, and disease staging) for PTEN IHC and NGS testing and for other protocol-mandated secondary and exploratory assessments. If only 12-14 slides are available, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor. Cytologic or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases is not acceptable
A valid PTEN IHC result (testingcentral laboratory tested with results directly sent to IxRS) (e.g., participants with an "invalid" or "failed" PTEN IHC result are not permitted to enroll)
Metastatic disease documented prior to randomization by clear evidence of bone lesions on bone scan and/or measurable soft tissue disease by computed tomography (CT) and/or magnetic resonance imaging (MRI) (at least one target lesion) according to RECIST v1.1
Asymptomatic or mildly symptomatic form of prostate cancer
Progressive disease before initiating study treatment
Ongoing androgen deprivation with gonadotropin-releasing hormone (GnRH) analog or bilateral orchiectomy, with serum testosterone <= 50 ng/dL (<= 1.7 nmol/L) within 28 days before randomization
Exclusion Criteria
1. Bilateral breast cancer.
2. Pregnancy or lactation or considering becoming pregnant.
3. Metastases, other than sentinel/axillary lymph nodes.
4. Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) for
invasive malignant disease or other concomitant malignancy, other than basal-cell
carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is allowed.
5. Previous treatment with Herceptin.
6. Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension; history of myocardial infarction or cardiac failure, New York Heart Association (NYHA) class II or higher; clinically significant cardiac valvular disease; hemodynamic effective pericardial effusion; other cardiomyopathies; LVEF of <55%.
7. Any investigational treatment less than 30 days prior to study entry, or within a
time interval less than at least 5 half-lives of the investigational medicinal product, whichever is longer.
8. Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or
human immunodeficiency virus (HIV).
9. History of hypersensitivity to drugs with similar chemical structures to trastuzumab.
10. History of, or known current problems with, drug or alcohol abuse.
11. Other serious illness, medical disorder or condition that, in the opinion of the
Investigator, would make the patient unsuitable for participation in the study.
2. Pregnancy or lactation or considering becoming pregnant.
3. Metastases, other than sentinel/axillary lymph nodes.
4. Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) for
invasive malignant disease or other concomitant malignancy, other than basal-cell
carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is allowed.
5. Previous treatment with Herceptin.
6. Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension; history of myocardial infarction or cardiac failure, New York Heart Association (NYHA) class II or higher; clinically significant cardiac valvular disease; hemodynamic effective pericardial effusion; other cardiomyopathies; LVEF of <55%.
7. Any investigational treatment less than 30 days prior to study entry, or within a
time interval less than at least 5 half-lives of the investigational medicinal product, whichever is longer.
8. Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or
human immunodeficiency virus (HIV).
9. History of hypersensitivity to drugs with similar chemical structures to trastuzumab.
10. History of, or known current problems with, drug or alcohol abuse.
11. Other serious illness, medical disorder or condition that, in the opinion of the
Investigator, would make the patient unsuitable for participation in the study.
The Estimated Number of Participants
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Taiwan
50 participants
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Global
800 participants
