計劃書編號EGC002
試驗已結束
2018-05-02 - 2022-01-20
Phase III
召募中6
終止收納1
ICD-10C50
乳房惡性腫瘤
一項隨機分配、多中心、雙盲設計的第3期試驗，評估EG12014 Trastuzumab 相較於Herceptin®作為HER2陽性早期乳癌病人進行含Anthracycline/Paclitaxel全身性治療時的前輔助治療的療效及安全性
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試驗申請者
台灣璞氏健康發展有限公司
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試驗委託 / 贊助單位名稱
EirGenix Inc. 台康生技股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/04/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
Audit
無
實際收案人數
0 召募中
Audit
無
實際收案人數
1 召募中
Audit
無
實際收案人數
0 終止收納
適應症
人類表皮生長因子受體2 (HER2) 陽性早期乳癌(EBC)
試驗目的
主要目標：
本試驗主要目標為是證明EG12014和Herceptin治療等效性，均合併使用paclitaxel 12週(4個週期)作為術前輔助療法。用於患有人類表皮生長因子受體2 (HER2) 陽性早期乳癌(EBC) 病患，依據中央實驗室評估之手術時病理學完全反應(pCR) (ypT0/is ypN0)判定療效。
次要目標：
• 進一步評估手術時的pCR (ypT0 ypN0及ypT0/is)。
• 評估無事件存活期(EFS)。
• 評估手術前整體反應(OR) ，依據RECIST版本1.1標準。
• 評估整體存活期(OS)。
• 比較EG12014和Herceptin在術前輔助治療期間的安全性資料，以及EG12014和Herceptin在整個試驗期間的安全性。
• 評估EG12014和Herceptin的免疫原性。
• 比較EG12014和Herceptin於術前輔助治療時的藥動學(PK)。
藥品名稱
Powder for Solution
主成份
Trastuzumab
劑型
Powder for Solution
劑量
mg
評估指標
主要評估指標：
• 手術時的pCR，其中pCR之定義為，依據中央實驗室評估，完全切除乳房檢體的蘇木紫與伊紅染色評估(不論是否為乳管原位癌[DCIS])以及所有採檢的前哨淋巴結和/或腋下淋巴結，均顯示無殘餘侵入性癌症 (ypT0/is ypN0)。
次要評估指標：
• 療效：
o 手術時的pCR，其中pCR之定義為，依據中央實驗室評估，乳房組織以及前哨/腋下淋巴結均顯示無殘餘侵入性癌症和乳管原位癌(DCIS, ypT0 ypN0)。
o 手術時的pCR，定義為依據中央實驗室評估僅有乳房組織顯示無侵入性癌症 (ypT0/is)。
o 直至試驗結束(EOS)時的無事件存活期(EFS)，定義為自初次隨機分配日期起至依據機構標準流程診斷為疾病復發或惡化(局部、區域性、遠端或對側)之時間、或至因任何原因死亡之日期(以較早者為準)的期間。
o 手術前的客觀緩解率，定義為依據RECIST版本1.1之部分反應(PR)或完全反應(CR)。
o 直至試驗結束(EOS)的整體存活期(OS)，定義為初次隨機分配日期起至死亡日期的期間。
• 手術時的pCR，其中pCR之定義為，依據中央實驗室評估，完全切除乳房檢體的蘇木紫與伊紅染色評估(不論是否為乳管原位癌[DCIS])以及所有採檢的前哨淋巴結和/或腋下淋巴結，均顯示無殘餘侵入性癌症 (ypT0/is ypN0)。
次要評估指標：
• 療效：
o 手術時的pCR，其中pCR之定義為，依據中央實驗室評估，乳房組織以及前哨/腋下淋巴結均顯示無殘餘侵入性癌症和乳管原位癌(DCIS, ypT0 ypN0)。
o 手術時的pCR，定義為依據中央實驗室評估僅有乳房組織顯示無侵入性癌症 (ypT0/is)。
o 直至試驗結束(EOS)時的無事件存活期(EFS)，定義為自初次隨機分配日期起至依據機構標準流程診斷為疾病復發或惡化(局部、區域性、遠端或對側)之時間、或至因任何原因死亡之日期(以較早者為準)的期間。
o 手術前的客觀緩解率，定義為依據RECIST版本1.1之部分反應(PR)或完全反應(CR)。
o 直至試驗結束(EOS)的整體存活期(OS)，定義為初次隨機分配日期起至死亡日期的期間。
主要納入條件
Patients will be entered into this study only if they meet all of the following criteria:
1. Provide signed and dated written informed consent before entering the study. The
informed consent will cover both parts of the study (neoadjuvant part and adjuvant
part).
2. Female, ≥18 and ≤65 years of age.
3. Histologically-confirmed invasive carcinoma of the breast (American Joint Committee on Cancer [AJCC, vs. 8.0] Stage II, IIIa [42]).
4. Operable breast cancer, planned surgical resection of breast tumor (mastectomy or
lumpectomy) and sentinel or axillary lymph nodes.
5. Unilateral, measurable tumor of the breast >2 cm in diameter (by ultrasound and/or
mammography).
6. HER2-positive tumor, defined as 3+ score by IHC or fluorescence positive by FISH, as confirmed by central laboratory.
7. Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry.
8. Adequate bone marrow function, defined as neutrophil count of ≥1.500/μL and platelet count of ≥100.000/μL.
9. Adequate hepatic and renal function, defined as:
bilirubin ≤2 x upper limit of normal (ULN)
alanine aminotransferase (ALT) ≤2 ULN
aspartate aminotransferase (AST) ≤2 x ULN
gamma glutamyl transferase (GGT) ≤3 x ULN
serum creatinine <1.5 ULN
10. International normalized ratio ≤1.5×ULN (2 to 3×ULN if on anticoagulants) or
prothrombin time ≤1.5×ULN; activated partial thromboplastin time ≤1.5×ULN.
11. Hemoglobin concentrations ≥10 g/dL.
12. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
13. LVEF ≥55%, measured by multiple-gated acquisition (MUGA) scan or echocardiography.
14. Negative pregnancy test at entry, women of childbearing potential have to use
contraceptives during the course of the study.
Inclusion Criterion after Surgery (Adjuvant Part of the Study)
After completion of the neoadjuvant part of the study and surgery, patients will be
eligible for double-blind adjuvant therapy with EG12014 or Herceptin if they meet the following criterion:
1. No sequelae have occurred after neoadjuvant therapy, in particular regarding cardiac function. No separate informed consent is required.
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.
1. Provide signed and dated written informed consent before entering the study. The
informed consent will cover both parts of the study (neoadjuvant part and adjuvant
part).
2. Female, ≥18 and ≤65 years of age.
3. Histologically-confirmed invasive carcinoma of the breast (American Joint Committee on Cancer [AJCC, vs. 8.0] Stage II, IIIa [42]).
4. Operable breast cancer, planned surgical resection of breast tumor (mastectomy or
lumpectomy) and sentinel or axillary lymph nodes.
5. Unilateral, measurable tumor of the breast >2 cm in diameter (by ultrasound and/or
mammography).
6. HER2-positive tumor, defined as 3+ score by IHC or fluorescence positive by FISH, as confirmed by central laboratory.
7. Known estrogen receptor (ER) and progesterone receptor (PrR) status at study entry.
8. Adequate bone marrow function, defined as neutrophil count of ≥1.500/μL and platelet count of ≥100.000/μL.
9. Adequate hepatic and renal function, defined as:
bilirubin ≤2 x upper limit of normal (ULN)
alanine aminotransferase (ALT) ≤2 ULN
aspartate aminotransferase (AST) ≤2 x ULN
gamma glutamyl transferase (GGT) ≤3 x ULN
serum creatinine <1.5 ULN
10. International normalized ratio ≤1.5×ULN (2 to 3×ULN if on anticoagulants) or
prothrombin time ≤1.5×ULN; activated partial thromboplastin time ≤1.5×ULN.
11. Hemoglobin concentrations ≥10 g/dL.
12. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
13. LVEF ≥55%, measured by multiple-gated acquisition (MUGA) scan or echocardiography.
14. Negative pregnancy test at entry, women of childbearing potential have to use
contraceptives during the course of the study.
Inclusion Criterion after Surgery (Adjuvant Part of the Study)
After completion of the neoadjuvant part of the study and surgery, patients will be
eligible for double-blind adjuvant therapy with EG12014 or Herceptin if they meet the following criterion:
1. No sequelae have occurred after neoadjuvant therapy, in particular regarding cardiac function. No separate informed consent is required.
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.
試驗計畫預計收納受試者人數
-
台灣人數
50 人
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全球人數
800 人
