To study Efiicacy and Safety of Pegstim Clinical Trial

Phase 3

Completed

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

• Registration Number: CTRI/2017/03/008142
• Lead Sponsor: Rus Biopharm LLC Russia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 87

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 <= 2;

6 Absolute neutrophil count >= 1.5Ã?109/L;

7 Haemoglobin concentration >= 90 g/L;

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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;