Clinical Trials List
Protocol NumberBIO-PERTUZ-301
NCT Number(ClinicalTrials.gov Identfier)NCT06038539
Completed
2023-10-02 - 2026-12-31
Phase III
Recruiting7
ICD-10C50.911
Malignant neoplasm of unspecified site of right female breast
ICD-10C50.912
Malignant neoplasm of unspecified site of left female breast
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9174.9
Malignant neoplasm of female breast, unspecified
A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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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
- 周旭桓 無
- Wen-Chi Shen 無
- Mengting Peng 無
- Shin-Cheh Chen 無
- Yung-Chang Lin Division of Hematology & Oncology
- Chia-Hui Chu 無
- Chan-Keng Yang 無
- 沈士哲 無
- Chi-Chang Yu 無
- 何蕙余 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 甘蓉瑜 無
- 高捷妮 無
- Junping Shiau Shiau 無
- Chung-Liang Li 無
- Chieh-Han Chuang 無
- 巫承哲 無
- 高理鈞 無
- Shen Liang Shih 無
- Fang-Ming Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-Hong Cheng 無
- 廖立民 無
- KA-WAI TAM 無
- HUI-WEN LIU 無
- Yao-Yu Hsieh 無
- Tsu-Yi Chao 無
- 莊博雅 無
- 蘇智銘 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 楊舜如 無
- Zhu-Jun Loh 無
- Chun-Hui Lee 無
- Kuo-Ting Lee 無
- Shang-Hung Chen 無
- Jui-Hung Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Objectives
The purpose of this study was to compare PERT-IJS plus trastuzumab and chemotherapy (carboplatin and docetaxel) with EU-Perjeta plus trastuzumab and chemotherapy in the pre-adjuvant setting in patients with HR-ve and HER-2-positive early or locally advanced breast cancer. (carboplatin and docetaxel) efficacy and safety.
Test Drug
PERT-IJS (Bmab 1500)
Active Ingredient
Pertuzumab
Dosage Form
Solution for infusion
Dosage
420mg/14mL
Endpoints
Main analysis of main evaluation indicators:
The primary efficacy analysis was designed to demonstrate equivalence of tpCR between treatment arm A and treatment arm B within predefined equivalence cutoffs. Overall pathological complete response will be assessed by the IRC.
To demonstrate tpCR equivalence between the two pre-adjuvant regimens, adjusted hazard ratios will be analyzed for the primary efficacy analysis in accordance with institutional recommendations. Equivalence was declared if the 90% Wald CI for the tpCR ratio between the two preadjuvant regimens was fully contained within the equivalence cutoff (0.79, 1.27).
The 90% Wald CI will be estimated using a stratified Cochran Mantel-Haenszel test with stratification factors for disease category and region. Analyzes will be performed using the ITT population (Part 1) and the PP population.
The primary efficacy analysis was designed to demonstrate equivalence of tpCR between treatment arm A and treatment arm B within predefined equivalence cutoffs. Overall pathological complete response will be assessed by the IRC.
To demonstrate tpCR equivalence between the two pre-adjuvant regimens, adjusted hazard ratios will be analyzed for the primary efficacy analysis in accordance with institutional recommendations. Equivalence was declared if the 90% Wald CI for the tpCR ratio between the two preadjuvant regimens was fully contained within the equivalence cutoff (0.79, 1.27).
The 90% Wald CI will be estimated using a stratified Cochran Mantel-Haenszel test with stratification factors for disease category and region. Analyzes will be performed using the ITT population (Part 1) and the PP population.
Inclution Criteria
Inclusion Criteria:
Patient willing and able to sign informed consent and to follow the protocol requirements
Female patients aged ≥ 18 years at the time of Screening
Patient with Eastern Cooperative Oncology Group (ECOG) Performance Status < 2
Patients with breast cancer that meets the following criteria:
A known case of histologically confirmed invasive breast carcinoma with a primary tumor size of > 2 cm by standard local assessment technique
stage at presentation: early stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4a-c, any N, M0) or inflammatory (T4d, any N, M0)
Patients with HER2 overexpression by Immunohistochemistry (IHC) (defined as IHC 3+, or IHC 2+ with Fluorescence In Situ Hybridization (FISH) confirmation) as per the American Society of Clinical Oncology/College of American Pathologist (ASCO-CAP) guidelines prior to Screening and confirmed centrally before randomization
Patients with known HR-ve status (ER-negative and PR-negative) as per local laboratory prior to Screening and confirmed centrally before randomization
Patient willing to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
Patient who completes all necessary baseline laboratory and radiologic investigations prior to randomization as per Schedule of assessment (SoA)
Patient with baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography (ECHO; preferred) or multiple-gated acquisition (MUGA) scan
Patient is eligible to participant if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Patient willing and able to sign informed consent and to follow the protocol requirements
Female patients aged ≥ 18 years at the time of Screening
Patient with Eastern Cooperative Oncology Group (ECOG) Performance Status < 2
Patients with breast cancer that meets the following criteria:
A known case of histologically confirmed invasive breast carcinoma with a primary tumor size of > 2 cm by standard local assessment technique
stage at presentation: early stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4a-c, any N, M0) or inflammatory (T4d, any N, M0)
Patients with HER2 overexpression by Immunohistochemistry (IHC) (defined as IHC 3+, or IHC 2+ with Fluorescence In Situ Hybridization (FISH) confirmation) as per the American Society of Clinical Oncology/College of American Pathologist (ASCO-CAP) guidelines prior to Screening and confirmed centrally before randomization
Patients with known HR-ve status (ER-negative and PR-negative) as per local laboratory prior to Screening and confirmed centrally before randomization
Patient willing to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
Patient who completes all necessary baseline laboratory and radiologic investigations prior to randomization as per Schedule of assessment (SoA)
Patient with baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography (ECHO; preferred) or multiple-gated acquisition (MUGA) scan
Patient is eligible to participant if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Exclusion Criteria
Exclusion Criteria:
Patients with metastatic or recurrent bilateral breast cancer, or bilateral breast cancer
Patients with a history of concurrent or previously treated non-breast malignancies. A patient with previous invasive non-breast cancer is eligible provided she has been disease free for more than 5 years
Patients who have received any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, and antitumor vaccines) for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
Concurrent anti-cancer treatment in another investigational study, including hormone therapy or immunotherapy
Major surgical procedure that is unrelated to breast cancer within 4 weeks prior to randomization or from which the patient has not fully recovered
Serious cardiac illness or medical condition including but not limited to the following as per Investigator's discretion:
Patients with ≥ Class II stage of heart failure as per New York Heart Association Classification
High risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate > 100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia) required treatment, or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block)
History of myocardial infarction or unstable angina pectoris within 1 year of randomization or angina pectoris requiring anti-anginal medication
Evidence of transmural infarction on ECG
Clinically significant valvular heart disease
Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) in patients on anti-hypertensive medications
Other concurrent serious diseases that may interfere with study primary endpoint and other study assessments, including, but not limited to, severe pulmonary conditions/illness, active liver disease (for example, active viral hepatitis infection [i.e., hepatitis B or hepatitis C]), autoimmune disorders, history of or known patient of sclerosing cholangitis, or infection with Human immune deficiency virus (HIV)
Patients with a history of any contraindication to the study treatment regimens
Any of the following abnormal laboratory test results prior to randomization:
Total bilirubin > upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin > 2 × ULN
Aspartate aminotransferase and/or alanine aminotransferase > 1.5 × ULN, if considered clinically significant by Investigator
Alkaline phosphatase >2.5 × ULN, if considered clinically significant by Investigator
Serum creatinine > 1.5 × ULN
Creatinine clearance < 60 mL/min
Total white blood cells count < 2500 cells/μL
Absolute neutrophil count < 2000 cells/μL
Platelet count < 100,000 cells/μL
Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within five half-lives (of the drug/ biologic) prior to the enrolment (whichever is longer)
Have taken any live vaccines 30 days prior to the 1st dose of study treatment
Any known hypersensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
Patients unwilling to follow the study requirements.
Presence of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the Investigator, may interfere with the interpretation of efficacy and safety parameters or has a medical condition for which the treatment should take precedence over study participation or will interfere with study participation
Patients with metastatic or recurrent bilateral breast cancer, or bilateral breast cancer
Patients with a history of concurrent or previously treated non-breast malignancies. A patient with previous invasive non-breast cancer is eligible provided she has been disease free for more than 5 years
Patients who have received any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, and antitumor vaccines) for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
Concurrent anti-cancer treatment in another investigational study, including hormone therapy or immunotherapy
Major surgical procedure that is unrelated to breast cancer within 4 weeks prior to randomization or from which the patient has not fully recovered
Serious cardiac illness or medical condition including but not limited to the following as per Investigator's discretion:
Patients with ≥ Class II stage of heart failure as per New York Heart Association Classification
High risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate > 100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia) required treatment, or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block)
History of myocardial infarction or unstable angina pectoris within 1 year of randomization or angina pectoris requiring anti-anginal medication
Evidence of transmural infarction on ECG
Clinically significant valvular heart disease
Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) in patients on anti-hypertensive medications
Other concurrent serious diseases that may interfere with study primary endpoint and other study assessments, including, but not limited to, severe pulmonary conditions/illness, active liver disease (for example, active viral hepatitis infection [i.e., hepatitis B or hepatitis C]), autoimmune disorders, history of or known patient of sclerosing cholangitis, or infection with Human immune deficiency virus (HIV)
Patients with a history of any contraindication to the study treatment regimens
Any of the following abnormal laboratory test results prior to randomization:
Total bilirubin > upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin > 2 × ULN
Aspartate aminotransferase and/or alanine aminotransferase > 1.5 × ULN, if considered clinically significant by Investigator
Alkaline phosphatase >2.5 × ULN, if considered clinically significant by Investigator
Serum creatinine > 1.5 × ULN
Creatinine clearance < 60 mL/min
Total white blood cells count < 2500 cells/μL
Absolute neutrophil count < 2000 cells/μL
Platelet count < 100,000 cells/μL
Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within five half-lives (of the drug/ biologic) prior to the enrolment (whichever is longer)
Have taken any live vaccines 30 days prior to the 1st dose of study treatment
Any known hypersensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
Patients unwilling to follow the study requirements.
Presence of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the Investigator, may interfere with the interpretation of efficacy and safety parameters or has a medical condition for which the treatment should take precedence over study participation or will interfere with study participation
The Estimated Number of Participants
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Taiwan
24 participants
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Global
382 participants
