Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Lupin's Pegfilgrastim; Drug: Neulasta®

• Registration Number: NCT03511378
• Lead Sponsor: Lupin Ltd.

Brief Summary

The purpose of this study is to compare the immunogenicity of Peg-filgrastim versus Neulasta® as an adjunct to chemotherapy in patients with breast cancer

Detailed Description

An open-label, randomized, comparative, parallel group study to assess the Immunogenicity of Lupin's Peg-filgrastim versus Neulasta® as an Adjunct to Chemotherapy in Patients with Breast Cancer

Primary Objective: To assess the immunogenicity of Lupin's Peg-filgrastim with Neulasta® in patients with breast cancer.

Secondary Objectives: To assess the safety of Lupin's Peg-filgrastim with Neulasta® in patients with breast cancer

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-27
• Primary Completion: 2019-01-09
• Study Completion: 2019-01-09
• Results First Submitted: 2020-09-30
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Results First Posted: 2021-06-15
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

Inclusion Criteria

1. Patients must be able and willing to give written informed consent prior to any study related procedures
2. Ambulatory, female patients with an age ≥ 18 years
3. Patients with histologically or cytologically proven diagnosis of breast cancer who are eligible for neoadjuvant or adjuvant chemotherapy.
4. Patients who are planned and eligible to receive/ receiving myelosuppressive chemotherapy regimen that contains at least one chemotherapeutic agent from docetaxel/ paclitaxel / doxorubicin/ cyclophosphamide/ epirubicin
5. Patients who have not received any hematopoietic growth factors (e.g. G-CSF, PegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) anytime in the past
6. Patients with baseline WBC ≥ LLN/ 3.5 x 109/L, ANC of ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and hemoglobin ≥ 8.5 g/dL
7. Patients with ECOG Performance status of ≤ 2
8. Patient who have estimated life expectancy of more than six months
9. No evidences of hemorrhage

Exclusion Criteria

1 Male patients

2. Hypersensitivity to any of the study drugs or its components like E.coli proteins or similar product

3. Patients weighing <45 Kg

4. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic disease in bone marrow or brain

5. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry or likely to receive radiotherapy during the study

6. Patients with prior bone marrow or stem cell transplantation

7. Patients with chronic use of oral corticosteroids (Except ≤ 20 mg/day dose of prednisolone/ equivalent steroids), immunotherapy, monoclonal antibody therapy and/or biological therapy or use of any other pegylated drug.

8. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy

9. Patients with any active infection which may require systemic antimicrobial therapy. Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase > 2.5 X Upper limits of normal (ULN), serum SGOT > 2.5 X ULN, SGPT > 2.5 X ULN, Total bilirubin > 1.5 X ULN and Creatinine > 1.5 X ULN of the reference range at the screening assessment]

10. Patients with seropositivity for HIV or HBV or HCV

11. Known cases of Sickle Cell Anemia

12. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening

13. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography

14. Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patient's involvement in the study or overall interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease]

15. Patients who have participated in another therapeutic clinical study within the past 30 days prior to screening, or are likely to simultaneously participate in another therapeutic clinical study

16. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.

17. Women of child-bearing potential who are not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last dose of study drug.

18. Pregnant and Breast feeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lupin's Pegfilgrastim	Lupin's Pegfilgrastim	6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.
Neulasta®	Neulasta®	6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.

Primary Outcome Measures

Name	Time	Method
Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).	End of cycle 4, Day 84	The difference in cumulative incidence of anti-pegfilgrastim antibodies (binding and neutralizing) (measured as difference in proportion of patients with antibodies) to Pegfilgrastim between study groups at the end of cycle 4 will be calculated. Those samples confirmed to be positive for binding antibodies were analyzed for presence of neutralizing antibodies to Pegfilgrastim.

Secondary Outcome Measures

Name	Time	Method
Secondary Immunogenicity Endpoint	Day 10, Day 21, Day 42, Day 63 and Day 84.	Comparison of incidence of anti-peg antibodies (binding \& neutralizing) (measured as difference in proportion of patients with antibodies) between treatment groups on Day 10, Day 21, Day 42, Day 63 and Day 84. Analysis population: ITT population
Comparison of Incidence of Anti-pegfilgrastim Antibodies (Binding & Neutralizing) to Pegfilgrastim Between Treatment Groups on Day 10, Day 21, Day 42, Day 63 and Day 84	Assessment at each study visit on Day 10, Day 21, Day 42, Day 63, Day 84	Comparison of incidence of anti-pegfilgrastim antibodies (binding \& neutralizing) (measured as difference in proportion of patients with antibodies) to pegfilgrastim between treatment groups on Day 10, Day 21, Day 42, Day 63, Day 84. Analysis population : ITT
Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84).	Day 84.	The presence of anti-peg antibodies (binding) (measured as difference in proportion of patients with antibodies) between treatment groups at the end of cycle 4 (Day 84) were compared and analysis for the ITT population

Trial Locations

Locations (17)

Kailash Cancer Hospital & Research Center; 🇮🇳 Vadodara, Gujarat, India

M S Patel Cancer Centre,; 🇮🇳 Gokal, Anand, India

Sterling Hospital; 🇮🇳 Nigdi, Maharashtra, India

Apple Hospital; 🇮🇳 Sūrat, Gujarat, India

Nirmal Hospital; 🇮🇳 Sūrat, Gujarat, India

Apollo Gleneagles Hospitals; 🇮🇳 Kolkata, West Bengal, India

Research & Development Department, HCG Cancer Center; 🇮🇳 Ahmedabad, Gujarat, India

Bhaktivedanta Hospital & Research Institute; 🇮🇳 Thāne, Maharashtra, India

City Cancer Center; 🇮🇳 Vijayawada, Andhra Pradesh, India

Shree Himalaya Cancer Hospital & Research Institute,; 🇮🇳 Vadodara, Gujarat, India

Adhar health Institute; 🇮🇳 Hisar, Haryana, India

Sri Venketeshwara Hospital, Dept of Medical oncology; 🇮🇳 Bengaluru, Karnataka, India

Acharya Tulsi Regional Cancer Treatment & Research Institute; 🇮🇳 Bīkaner, Rajahstan, India

Clinical Research Department; 🇮🇳 Bande, Nagpur, India

Curie Manavata Cancer Centre; 🇮🇳 Mumbai, Maharashtra, India

Government Medical College & Hospital; 🇮🇳 Nagpur, Maharashtra, India

Global Clinical Research Services Pvt Ltd.; 🇮🇳 Hyderabad, Telangana, India