Clinical trial NCT03511378: Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast Carcinoma
Breast neoplasms
Breast Tumors
Cancer of Breast
Anti-Drug Antibodies (ADA)
Immunogenicity
Lead sponsor: Lupin Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).
timeFrame: End of cycle 4, Day 84
Secondary outcomes:
measure: Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84).
timeFrame: Day 84.
measure: 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
timeFrame: Assessment at each study visit on Day 10, Day 21, Day 42, Day 63, Day 84
measure: Secondary Immunogenicity Endpoint
timeFrame: Day 10, Day 21, Day 42, Day 63 and Day 84.
Other outcomes:
Locations:
city: Gokal
country: India
facility: M S Patel Cancer Centre,
state: Anand
city: Vijayawada
country: India
facility: City Cancer Center
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Research & Development Department, HCG Cancer Center
state: Gujarat
city: Sūrat
country: India
facility: Apple Hospital
state: Gujarat
city: Sūrat
country: India
facility: Nirmal Hospital
state: Gujarat
city: Vadodara
country: India
facility: Shree Himalaya Cancer Hospital & Research Institute,
state: Gujarat
city: Vadodara
country: India
facility: Kailash Cancer Hospital & Research Center
state: Gujarat
city: Hisar
country: India
facility: Adhar health Institute
state: Haryana
city: Bengaluru
country: India
facility: Sri Venketeshwara Hospital, Dept of Medical oncology
state: Karnataka
city: Mumbai
country: India
facility: Curie Manavata Cancer Centre
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College & Hospital
state: Maharashtra
city: Nigdi
country: India
facility: Sterling Hospital
state: Maharashtra
city: Thāne
country: India
facility: Bhaktivedanta Hospital & Research Institute
state: Maharashtra
city: Bande
country: India
facility: Clinical Research Department
state: Nagpur
city: Bīkaner
country: India
facility: Acharya Tulsi Regional Cancer Treatment & Research Institute
state: Rajahstan
city: Hyderabad
country: India
facility: Global Clinical Research Services Pvt Ltd.
state: Telangana
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals
state: West Bengal
Study officials:
affiliation: Lupin Limited
name: Dhananjay Bakhle, MD
role: STUDY_DIRECTOR
References: