Health Condition 1: C50-C50- Malignant neoplasms of breast
Conditions
Interventions
Intervention1: Biosimilar Pertuzumab: Dosage Form:
The initial loading dose of Pertuzumab is 840 mg administered as a 60-minute intravenous
infusion, followed every 3 weeks thereafter by a maintenan
Sponsors
Enzene Biosciences Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients 18 to 65 years of age (both inclusive). 2. Patient with pathologically (histologically or cytologically) confirmed breast cancer with stage IV i.e. Metastatic disease, atleast M1 as per AJCC TNM classification 3. With at least one measurable metastatic target lesion (based on RECIST criteria, version1.1). 4. Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH); as defined by a ratio >2.0) OR documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) 5. Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 2. 6. Left ventricular ejection fraction (LVEF) of = 50% at screening visit 7. Has life expectancy of at least 6 months from screening 8. Patient willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of severe hypersensitivity reaction to Pertuzumab, Trastuzumab or Docetaxel or any of its excipients 2. Prior systemic therapy for metastatic disease, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. Lapatinib), biological drugs (e.g. Trastuzumab and Bevacizumab), experimental drugs (not approved for breast cancer therapy, anticancer drugs (except prior single hormonal therapy) 3. History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of 4. History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting. 5. Has received cumulative doses of anthracycline, exceeding 360 mg/m2 of BSA for doxorubicin, 720 mg/m2 of BSA for epirubicin, 120 mg/m2 of BSA for mitoxantrone, and 90 mg/m2 of BSA for idarubicin. 6. Has active and uncontrolled metastasis to central nervous system 7. Has bone metastasis as the only measurable tumor 8. Has Preexisting Grade 3 or higher sensory or motor peripheral neuropathy at randomization. 9. Has history of congestive heart failure of any New York Heart Association (NYHA) class, serious cardiac arrhythmia requiring treatment, unstable angina pectoris, and/or myocardial infarction within 6 months prior to screening 10. Has uncontrolled hypertension at screening (i.e. SBP = 140 mmHg and/or DBP = 90mmHg) 11. Has severe dyspnea at rest or requiring supplementary oxygen therapy 12. Has undergone any prior mediastinal irradiation (except internal mammary node irradiation) for the present breast cancer 13. Patient’s having the following laboratory results at screening a. Absolute neutrophil count (ANC) b. Hemoglobin (Hb) c. Total Leucocyte count d. Platelet count e. Total bilirubin level >1.5 times the upper limit of the normal laboratory range (ULN)( > 2.5 times ULN in patients with liver metastases) f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3.0 x upper limit of normal (ULN) ( >5 x ULN in patients with liver metastases) g. Alkaline phosphatase > 2.5 x ULN ( > 5.0 x ULN if liver or bone metastases are present) h. Serum Creatinine level > 1.5 times ULN 14. Patients suffering from acute or chronic infection(s) 15. Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening 16. Female patients of childbearing potential not willing to implement adequate non-hormonal contraceptive measures during the study period 17. Patients who are pregnant or nursing 18. Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment 19. Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the patient in this study 20. Has partici
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of biosimilar Pertuzumab versus innovator Pertuzumab in Previously Untreated Patients with HER2 Positive Metastatic Breast Cancer by assessment of DCRTimepoint: 1. All patients completed 9 Week of treatment. 2. All patients completed 18 week of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Response Rate (ORR) 2. Pharmacokinetics (PK) profile of biosimilar Pertuzumab versus Innovator Pertuzumab (Perjeta®, Genentech Inc.,). 3. Immunogenicity potential of biosimilar Pertuzumab and comparison with Perjeta Innovator Pertuzumab by assessment of anti-pertuzumab antibody 4. Safety and tolerability of the investigational productTimepoint: Overall Response Assessment- Week 9 and Week 18 Anti-Pertuzumab Antibody(ADA)- Visit 2, Visit 8 PK Assessment- Visit 2 | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratories Limited
Outcome results
None listed