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

NCT03511378 | Completed Phase 4 Results FDA Drug

• 1 other identifier: LRP/PegGCSF/2016/004
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 17

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

Conditions

Breast Cancer

Keywords

Breast Carcinoma; Breast neoplasms; Breast Tumors; Cancer of Breast; Anti-Drug Antibodies (ADA); Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the 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.

  End of cycle 4, Day 84

Secondary Outcomes (3)

• Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84).

  Day 84.

• 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

• Secondary Immunogenicity Endpoint

  Day 10, Day 21, Day 42, Day 63 and Day 84.

Study Arms (2)

Lupin's Pegfilgrastim

EXPERIMENTAL

6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.

Drug: Lupin's Pegfilgrastim

Neulasta®

EXPERIMENTAL

6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4.

Drug: Neulasta®

Interventions

Lupin's Pegfilgrastim DRUG

Administration of Pegfilgrastim

Also known as: INvestigational product

Lupin's Pegfilgrastim

Neulasta® DRUG

Administration of Neulasta®

Also known as: Reference

Neulasta®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able and willing to give written informed consent prior to any study related procedures
• Ambulatory, female patients with an age ≥ 18 years
• Patients with histologically or cytologically proven diagnosis of breast cancer who are eligible for neoadjuvant or adjuvant chemotherapy.
• 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
• 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
• 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
• Patients with ECOG Performance status of ≤ 2
• Patient who have estimated life expectancy of more than six months
• No evidences of hemorrhage

You may not qualify if:

• Male patients
• \. Hypersensitivity to any of the study drugs or its components like E.coli proteins or similar product
• \. Patients weighing \<45 Kg
• \. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic disease in bone marrow or brain
• \. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry or likely to receive radiotherapy during the study
• \. Patients with prior bone marrow or stem cell transplantation
• \. 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.
• \. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy
• \. Patients with any active infection which may require systemic antimicrobial therapy. Patients with inadequate hepatic and renal function \[defined as Alkaline Phosphatase \> 2.5 X Upper limits of normal (ULN), serum SGOT \> 2.5 X ULN, SGPT \> 2.5 X ULN, Total bilirubin \> 1.5 X ULN and Creatinine \> 1.5 X ULN of the reference range at the screening assessment\]
• \. Patients with seropositivity for HIV or HBV or HCV
• \. Known cases of Sickle Cell Anemia
• \. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening
• \. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography
• \. 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. \[for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease\]
• \. 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

Sponsors & Collaborators

• Lupin Ltd.: lead

Study Sites (17)

M S Patel Cancer Centre,

Gokal, Anand, 388325, India

Location

City Cancer Center

Vijayawada, Andhra Pradesh, 520002, India

Location

Research & Development Department, HCG Cancer Center

Ahmedabad, Gujarat, 380006, India

Location

Apple Hospital

Surat, Gujarat, 395002, India

Location

Nirmal Hospital

Surat, Gujarat, 395002, India

Location

Shree Himalaya Cancer Hospital & Research Institute,

Vadodara, Gujarat, 390007, India

Location

Kailash Cancer Hospital & Research Center

Vadodara, Gujarat, 391760, India

Location

Adhar health Institute

Hisar, Haryana, 125001, India

Location

Sri Venketeshwara Hospital, Dept of Medical oncology

Bengaluru, Karnataka, 560068, India

Location

Curie Manavata Cancer Centre

Mumbai, Maharashtra, Nasik- 422004, India

Location

Government Medical College & Hospital

Nagpur, Maharashtra, 440009, India

Location

Sterling Hospital

Nigdi, Maharashtra, 411044, India

Location

Bhaktivedanta Hospital & Research Institute

Thane, Maharashtra, 401107, India

Location

Clinical Research Department

Bande, Nagpur, 44026, India

Location

Acharya Tulsi Regional Cancer Treatment & Research Institute

Bīkaner, Rajahstan, 334003, India

Location

Global Clinical Research Services Pvt Ltd.

Hyderabad, Telangana, 500004, India

Location

Apollo Gleneagles Hospitals

Kolkata, West Bengal, 7000054, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Chirag Shah, Director
• Organization: Lupin Ltd. (Lupin Research Park), Pune, India

chiragshah@lupin.com

91-20-67917368

Study Officials

• Dhananjay Bakhle, MD

  Lupin Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 27, 2018
• Study Start: March 6, 2018
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (17)