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CTRI Number  CTRI/2025/01/079576 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of low dose versus standard dose of peg gcsf in patient receiving chemotherapy in breast cancer.  
Scientific Title of Study   Comparative study of 06 mg versus 03 mg of peg gcsf in patient receiving adjuvant and/or neoadjuvant dose-dense adriamycin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC) in breast cancer treatment protocols 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharmendra Singh 
Designation  Senior Resident Medical Oncology 
Affiliation  Army hospital research and referral  
Address  Department of medical oncology, Army Hospital research and referral, New Delhi 110010.

South West
DELHI
110010
India 
Phone  7507081007  
Fax    
Email  docd5321@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepak Mulajker  
Designation  Professor medicine and medical oncolologist 
Affiliation  Army hospital research and referral 
Address  Department of medical oncology army hospital research and referral, New Delhi 110010.

South West
DELHI
110010
India 
Phone  7506117152  
Fax    
Email  djbydsm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dharmendra Singh 
Designation  Senior resident medical oncology  
Affiliation  Army Hospital research and referral  
Address  Department of medical oncology, army hospital research and referral, New Delhi 110010.

South West
DELHI
110010
India 
Phone  7507081007  
Fax    
Email  docd5321@gmail.com  
 
Source of Monetary or Material Support  
Department of medical oncology, Army hospital research and referral, New Delhi India 110010. 
 
Primary Sponsor  
Name  Army Hospital Research and referral New Delhi 
Address  Department of medical oncology, Army hospital research and referral New Delhi 110010. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dharmendra Singh   Army Hospital Research and referral New Delhi   Room number 12, Department of medical oncology, first floor, Army hospital research and referral, New Delhi 110010.
South West
DELHI 
7507081007

docd5321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Army hospital research and referral Delhi cantt  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  03 mg peg gcsf  03 mg peg gcsf will be given on day two of each dose dense adriamycin and cyclophosphamide (AC) or eprirubicine and cyclophosphamide (EC) in breast cancer treatment protocol. Total 04 such injection will be received by each patient every two weekly post chemotherapy. Total duration of intervention for each patient will be 02 months. 
Comparator Agent  06 mg peg gcsf  06 mg peg gcsf will be given on day two of each dose dense adriamycin and cyclophosphamide (AC) or eprirubicine and cyclophosphamide (EC) in breast cancer treatment protocol. Total 4 such injection will be received by each patient every two weekly post chemotherapy. total duration for each patient will be 02 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Female aged 18–65 years, pathohistological and clinical diagnosis of stage II or III primary invasive breast carcinoma, Eastern Cooperative Oncology Group performance status ≤2, Baseline normal CBC biochemistry and left ventricular ejection fraction more than 50 %
 
 
ExclusionCriteria 
Details  female aged less than 18 years and more than 65 years and patients who had a history of radiation therapy before chemotherapy, a history of stem cell or bone marrow transplantation, or comorbid malignancies other than breast cancer
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of chemotherapy induced grade IV neutropenia in both arms  Complete blood counts will be done at baseline and after 01 week in first cycle. Complete blood counts will be done on day of each chemotherapy cycle at baseline from cycle 02 onwards that is every 02 weekly. total duration will be 02 months for each patient. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of Febrile neutropenia in both arms  Incidence of Febrile neutropenia in both arms during dose dense chemotherapy  
Need of additional dose of GCSF   Need of additional dose of GCSF during dose dense chemotherapy 
Delay in the subsequent cycle of chemotherapy that is defined by more than 3 days delay in next cycle  Delay in the subsequent cycle of chemotherapy that is defined by more than 3 days delay in next cycle during dose dense chemotherapy 
Comparison of adverse events profiles of both arms  Comparison of adverse events profiles of both arms during dose dense chemotherapy 
 
Target Sample Size   Total Sample Size="382"
Sample Size from India="382" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [docd5321@gmail.com].

  6. For how long will this data be available start date provided 15-01-2028 and end date provided 15-01-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The use of pegfilgrastim, a long-acting granulocyte-colony stimulating factor (G-CSF), has improved the management of chemotherapy-induced neutropenia. Neutropenia is one of the most common adverse effects of chemotherapy and can result in serious infections, hospitalisations, and dose reductions, which can compromise the effectiveness of chemotherapy. Pegylated filgrastim is a modified form of G-CSF that has a longer half-life and can reduce the frequency of dosing compared to non-pegylated formulations.

Several studies have compared the efficacy and safety of low-dose 3 mg pegfilgrastim (Peg-3) with the standard 6 mg dose (Peg-6) in patients receiving chemotherapy. This was based on the comparable pharmacokinetics of 60mcg/kg and 100mcg/kg doses. Overall, these studies have shown that Peg-3 is non-inferior to Peg-6 in terms of its ability to reduce the duration and severity of chemotherapy-induced neutropenia, the incidence of febrile neutropenia, and the need for dose reductions or delays.

 

One randomised, double-blind, phase III study compared the efficacy and safety of Peg-3 with Peg-6 in patients with breast cancer receiving docetaxel and cyclophosphamide chemotherapy. The study found no significant difference between the two groups in terms of the incidence of febrile neutropenia, the duration of severe neutropenia, or the need for dose reduction or delays. Other studies have reported similar findings, showing no significant differences in efficacy between Peg-3 and Peg-6 in various chemotherapy regimens, including those for colorectal cancer, lung cancer, and urothelial carcinoma. In terms of safety, both Peg-3 and Peg-6 have been well-tolerated, with similar rates of adverse events reported in clinical trials.

In conclusion, the use of low-dose 3 mg pegfilgrastim is a viable and effective option for the prevention of chemotherapy-induced neutropenia. The available literature suggests that Peg-3 is non-inferior to Peg-6 in terms of its ability to reduce the duration and severity of neutropenia, the incidence of febrile neutropenia, and the need for dose reductions or delays. As such, Peg-3 may offer some advantages over Peg-6, including reduced cost and potentially lower risk of adverse events. Further studies are needed to confirm these findings and determine the optimal dosing strategy for pegfilgrastim in different patient populations. 
The use of low-dose Peg GCSF has not been well studied thoroughly in India.. In this study, we are comparing 3 mg Peg GCSF vs 6 mg in carcinoma breast patients receiving AC/EC in neoadjuvant/adjuvant setting.   

 

 
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