| 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
|
|
|
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
|
|
|
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
|
|
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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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [docd5321@gmail.com].
- 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.
- 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. |