Status:
RECRUITING
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
Lead Sponsor:
Biocon Biologics UK Ltd
Conditions:
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Eligibility:
FEMALE
18-99 years
Phase:
PHASE3
Brief Summary
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carbo...
Detailed Description
This study is designed to compare the efficacy and safety of proposed biosimilar PERT-IJS plus trastuzumab, carboplatin and docetaxel versus EU-Perjeta plus trastuzumab, carboplatin and docetaxel in n...
Eligibility Criteria
Inclusion
- 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
- 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
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Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT06038539
Start Date
January 6 2025
End Date
November 15 2026
Last Update
June 25 2025
Active Locations (1)
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1
Chopda Medicare & Research Centre Pvt. Ltd,
Nashik, India, 422005