To study Efiicacy and Safety of Pegstim Clinical Trial

A single blind, comparative, multicentre, randomized study of the efficacy and safety of Pegstim, solution for subcutaneous injection, 6 mg/0.6 mL (Cadila Healthcare Ltd., India), and Neulastim, solution for subcutaneous injection, 6 mg/0.6 mL (Amgen Manufacturing Limited, USA), in patients diagnosed with breast cancer who receive myelosuppressive chemotherapy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008142

Enrollment

Registered

2017-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- In patients diagnosed with breast cancer who receive myelosuppressive chemotherapy

Interventions

Intervention1: Pegstim, solution for subcutaneous injection, 6 mg/0.6 mL.: Subcutaneously, 6 mg (one pre-filled syringe) 24 hours after the administration of cytotoxic chemotherapeutic agents. Control

Eligibility

Inclusion criteria

Inclusion criteria: 1 Verified diagnosis of breast cancer, stage I - III; 2 Indication for the ADtx chemotherapy regimen (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2); A need for >= 4 chemotherapy courses; 3 Cumulative doxorubicin dose (during the whole life) not exceeding 550 mg/m2; 4 Life expectancy exceeding 7 months; 5 ECG Performance Status 6 Absolute neutrophil count >= 1.5Ã?109/L; 7 Haemoglobin concentration >= 90 g/L;

Exclusion criteria

Exclusion criteria: 1 Body weight less than 45 kg; 2 More than one line of chemotherapy administered prior to screening in connection with breast cancer; 3 Preceding chemotherapy in connection with breast cancer less than 30 days prior to screening; 4 A history of other malignant tumors, except for patients having no signs of disease for the last 5 years and patients with a fully cured basal cell carcinoma of the skin; 5 A history of treatment with colony-stimulating factors; 6 Radiation therapy within 4 weeks prior to screening; 7 A history of bone marrow transplantation; 8 Hypersensitivity to proteins obtained using E. coli, or to any other component of the investigational medicinal product / reference product; 9 Hypersensitivity to doxorubicin and / or docetaxel and / or polysorbate 80; 10 Hereditary fructose intolerance;

Design outcomes

Primary

Measure	Time frame
Duration (days) of grade 4 neutropenia (ANC (absolute neutrophil count) 0.5 Ã? 109/L)Timepoint: after the 1st course of chemotherapy;	—

Secondary

Measure	Time frame
Duration (days) of grade 4 neutropenia (ANC (absolute neutrophil count) 0.5 Ã? 109/L)Timepoint: after the 2nd, the 3rd, and the 4th courses of chemotherapy;	—

Countries

India, Russian Federation

Contacts

Public ContactDr Mangesh khadakban

Nexus Clinical Research (India) Ltd.

mangesh.khadakban@nexuscro.com09167243914

Outcome results

None listed

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