Breast CancerPhase 4NCT03511378
Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer
A Phase 4 study testing Lupin's Pegfilgrastim and Neulasta® in people with Breast Cancer, run by Lupin Ltd. at 17 sites in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lupin's Pegfilgrastim and Neulasta®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 17 sitesIndia
- Study dates
- 6 Mar 2018to 9 Jan 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Patients with ECOG Performance status of ≤ 2
- Patient who have estimated life expectancy of more than six months
- No evidences of hemorrhage
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
India17 sites
Research & Development Department, HCG Cancer Center
Ahmedabad, Gujarat, 380006
Clinical Research Department
Bande, Nagpur, 44026
Sri Venketeshwara Hospital, Dept of Medical oncology
Bengaluru, Karnataka, 560068
Acharya Tulsi Regional Cancer Treatment & Research Institute
Bīkaner, Rajahstan, 334003
M S Patel Cancer Centre,
Gokal, Anand, 388325
Adhar health Institute
Hisar, Haryana, 125001
Global Clinical Research Services Pvt Ltd.
Hyderabad, Telangana, 500004
Apollo Gleneagles Hospitals
Kolkata, West Bengal, 7000054
Curie Manavata Cancer Centre
Mumbai, Maharashtra, Nasik- 422004
Government Medical College & Hospital
Nagpur, Maharashtra, 440009
Sterling Hospital
Nigdi, Maharashtra, 411044
Apple Hospital
Surat, Gujarat, 395002
Nirmal Hospital
Surat, Gujarat, 395002
Bhaktivedanta Hospital & Research Institute
Thane, Maharashtra, 401107
Shree Himalaya Cancer Hospital & Research Institute,
Vadodara, Gujarat, 390007
Kailash Cancer Hospital & Research Center
Vadodara, Gujarat, 391760
City Cancer Center
Vijayawada, Andhra Pradesh, 520002
About this study
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
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
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Lupin's Pegfilgrastim, Neulasta®
- Keywords
- Breast Carcinoma, Breast neoplasms, Breast Tumors, Cancer of Breast, Anti-Drug Antibodies (ADA), Immunogenicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lupin's PegfilgrastimDrug
Also called INvestigational product
Administration of Pegfilgrastim
Neulasta®Drug
Also called Reference
Administration of Neulasta®
| Study group | Role | What they receive |
|---|---|---|
| Lupin's Pegfilgrastim | Experimental | 6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4. Receives: Drug: Lupin's Pegfilgrastim |
| Neulasta® | Experimental | 6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4. Receives: Drug: Neulasta® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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
Measured: 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
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
Measured: Assessment at each study visit on Day 10, Day 21, Day 42, Day 63, Day 84
Secondary Immunogenicity Endpoint
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
Measured: Day 10, Day 21, Day 42, Day 63 and Day 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start6 Mar 2018
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lupin Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dhananjay Bakhle, MD, Study director, Lupin Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511378
- Sponsor's protocol ID
- LRP/PegGCSF/2016/004
- Status last verified
- May 2021
- First submitted
- 20 Mar 2018
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03511378
- Acronym / sponsor ID
- LRP/PegGCSF/2016/004
- Conditions
- Breast Cancer
- Keywords
- Breast Carcinoma, Breast neoplasms, Breast Tumors, Cancer of Breast, Anti-Drug Antibodies (ADA), Immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Lupin Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lupin's Pegfilgrastim | Experimental | Drug: Lupin's Pegfilgrastim6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4. |
| Neulasta® | Experimental | Drug: Neulasta®6 mg, subcutaneous injection on day 2/3 of each 21 ± 3 day cycle. Number of cycles: 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lupin's PegfilgrastimAlso: INvestigational productAdministration of Pegfilgrastim | Drug | Lupin's Pegfilgrastim |
| Neulasta®Also: ReferenceAdministration of Neulasta® | Drug | Neulasta® |
Primary outcome
Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84).
Time frame: 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.
3 secondary outcomes
Comparison of Cumulative Incidence of Anti-peg Antibodies (Binding and Neutralizing) Between Treatment Groups at the End of Cycle 4 (Day 84).
Time frame: 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
Time frame: Assessment at each study visit on Day 10, Day 21, Day 42, Day 63, Day 84
Secondary Immunogenicity Endpoint
Time frame: Day 10, Day 21, Day 42, Day 63 and Day 84.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhananjay Bakhle, MD study director
Lupin Limited
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lupin's Pegfilgrastim and Neulasta® in people with Breast Cancer, run by Lupin Ltd. at 17 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: End of cycle 4, Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.