Comparing the Safety and Efficacy of USV Pegfilgrastim and Neulasta® in Breast Cancer Patients

Phase 3

• Conditions: Health Condition 1: null- Chemotherapy-induced neutropenia in breast cancer

• Registration Number: CTRI/2014/09/005007
• Lead Sponsor: SV Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Female >=18 and <=65 years of age;

2.Patient who has provided written informed consent;

3. Chemotherapy naive patient with documented high risk stage II, or stage III or stage IV breast cancer (classification according to American Joint Committee on Cancer-AJCC;

4.Patient scheduled to receive chemotherapy comprising of docetaxel (75 mg/m2) and doxorubicin (60mg/m2) for their breast cancer disease;

5.Estimated life expectancy more than 6 months;

6. ECOG Performance [Appendix 5] Status <= 2 as determined within 7 days prior to Day 1 of Cycle 1 of chemotherapy;

7.Adequate bone marrow function, as determined within 7 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by:

•Hb >=9 g/dL (transfusion permitted during study);

•ANC >=1.5 x 109/L (>=1500/mm³);

•Platelet count >=100,000/μL (>=100 x 109/L).

8. Adequate renal and hepatic function, as determined within 7 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by:

•Creatinine <1.5 x Upper Limit of Normal (ULN);

• Total bilirubin within normal reference range (unless elevation is known to be due to Gilbertâ??s disease);

Patients must also meet one of the following criteria:

•Alkaline phosphatise (ALP) within normal reference range and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5 x ULN or

•Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN or

•Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range.

Exclusion Criteria

1.Previous therapy with any Granulocyte-Colony Stimulating Factor (G-CSF) and Pegfilgrastim preparation;

2.Patients with history of severe chronic neutropenia (congenital, cyclic or

idiopathic);

3.Patients with history of chronic myeloid leukaemia or myelodysplastic syndrome;

4.Previous or concurrent malignancy except non-invasive non-melanomatous skin cancer, in-situ carcinoma of cervix, or other solid tumour treated curatively and without evidence of recurrence for at least 2 years prior to study entry;

5.Patient who require concurrent radiotherapy or have radiotherapy within the 4 weeks prior to the first dose of chemotherapy, except for localized spot radiotherapy for bone metastases (Day 1 of Cycle 1)

6.Patient who is having concurrent anti-cancer therapy, including endocrine therapy (with the exception of corticosteroids at doses <=20 mg/day prednisolone or equivalent), immunotherapy, monoclonal antibody therapy and/or biological therapy;

7.Patient with chronic use of oral corticosteroids;

8.Concurrent treatment with bisphosphonates (unless the patient has been on a stable dose for four weeks prior to the first dose of chemotherapy [Day 1 of Cycle 1]);

9.Underlying neuropathy of grade 2 or higher;

10.Concurrent treatment with lithium;

11.Patients with prior bone marrow or stem cell transplantation;

12.Patients with leukocyte count more than 50 x 109/L;

13.Patients with cough, fever, dyspnoea in association with radiologic signs of pulmonary infiltrates at study entry;

14.Patient with clinically significant cardiac dysfunction at the time of screening, clinically significant findings on echocardiogram ( Ejection Fraction [EF] less than 50%) or a history of myocardial infarction or heart failure within 6 months preceding the first treatment cycle;

15.Brain metastases that are clinically symptomatic or being treated with steroids;

16.Patient with known hypersensitivity to E. Coli proteins or any of the excipients used in the test products;

17.Patients with rare hereditary problems of fructose intolerance, sickle cell disorders

18.Patients with positive serology for HIV1/2, Hepatitis B virus and/or Hepatitis C virus;

19.Pregnant or breast feeding women. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to Screening

20.Patient of childbearing potential unwilling to use a barrier method of contraception. It is required that a barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients (or their partners) of childbearing potential regardless of whether a hormonal agent also is used as a method of contraception

21.Patient with known active drug addiction, including alcoholism;

22.Patient with systemic disease that may interfere with safety, compliance, response to the product under investigation or its evaluation;

23.Patient with co-existing active infection or have received systemic anti-infectives for the treatment of infection within 72 hours prior to the first dose of chemotherapy (Day 1 of Cycle 1);

24.Patient with symptomatic anaemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified