Comparative study of low dose versus standard dose of peg gcsf in patient receiving chemotherapy in breast cancer.

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 - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079576

Enrollment

382

Registered

2025-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: 6 MG PEG GCSF: COMPARATIVE STUDY OF 06 MG VERSUS 03 MG OF PEG GCSF IN PATIENTS RECEIVING ADJUVANT AND/OR NEOADJUVANT DOSE-DENSE ADRIAMYCIN AND CYCLOPHOSPHAMIDE (AC) OR EPIRUBICIN AND CY

Eligibility

Inclusion criteria

Inclusion criteria: 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 %

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Incidence of chemotherapy induced grade IV neutropenia in both armsTimepoint: 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

Measure	Time frame
Incidence of Febrile neutropenia in both armsTimepoint: Incidence of Febrile neutropenia in both arms during dose dense chemotherapy;Need of additional dose of GCSFTimepoint: 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 cycleTimepoint: 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 armsTimepoint: Comparison of adverse events profiles of both arms during dose dense chemotherapy	—

Measure

Time frame

Incidence of Febrile neutropenia in both armsTimepoint: Incidence of Febrile neutropenia in both arms during dose dense chemotherapy;Need of additional dose of GCSFTimepoint: 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 cycleTimepoint: 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 armsTimepoint: Comparison of adverse events profiles of both arms during dose dense chemotherapy

—

Countries

India

Contacts

Public ContactDharmendra Singh

Army hospital research and referral

djbydsm@gmail.com7506117152

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026