A post marketing surveillance trial to study the safety and efficacy of two drugs, Neupeg and Neulastim in female patients with advanced breast cancer

Phase 4

• Conditions: Advanced(Stage III & IV) Breast Cancer

• Registration Number: CTRI/2010/091/000109
• Lead Sponsor: Intas Biopharmaceuticals Limited

Brief Summary

?A Prospective, Comparative, Randomized, Multicenteric, Open label Post Marketing Surveillance study to compare the Safety and efficacy of once-per-cycle Peg Filgrastim (6 mg/0.6 ml) of Intas Biopharmaceuticals Ltd. to NEULASTIM of ROCHE in support of AT chemotherapy in females patients with Advanced (Stage III and IV) breast cancer?

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

• 1.Female Patients aged 18 years and above suffering from advanced (Stage III and IV) Breast Cancer eligible for receiving AT (Docetaxel- 75 mg/m2, Doxorubicin- 50 mg/m2) chemotherapy.
• 2.GCSF and Peg- GCSF naive patients3.ANC > 1,500/uL4.Hemoglobin > 9 g/dL5.Platelets > 100,000/ul6.Patients with serum creatinine ≤ 1.5 mg/dL 7.AST/ALT < 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Bilirubin ≤ 2 x ULN 8.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study 9.Patients able to adhere to the study visit schedule and other protocol requirements10.Completion of previous chemotherapy more than 4 weeks before randomization.

Exclusion Criteria

• 1.History of prior malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukemia?s) or Any premalignant myeloid condition other than breast cancer with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy ? 2.Documented active infection at the time of enrolment requiring use of systemic anti- infective or use of any anti infective ≤ 72 hours before the study drug administration.3.Documented positive test for human immunodeficiency virus (HIV) infection ? known hypersensitivity to E coli derived products [e.g., Filgrastim pegfilgrastim HUMULIN® Insulin, L-1Asparaginase, HUMATROPE® Growth Hormone, INTRON A®] 4.Subject is currently enrolled in or 4 weeks have not passed since completing other device or drug trial(s) or is receiving other investigational agent(s) other than placebo (confirmation of prior treatment must be documented) 5.Pregnant or breast-feeding (for subjects of child bearing potential) patients or patients not using adequate contraception (for subjects of child bearing potential) 6.Previous participation in this study.
• Inability or unwillingness to comply with the protocol procedures7.Had undergone prior radiation therapy within 4 weeks of randomization into this study (with the exception of spot radiation for bone metastases), 8.Prior bone marrow or stem-cell transplantation, or Prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m2 or epirubicin more than 600 mg/m2.9.Clinically symptomatic brain metastasis.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint will be	Duration of severe Neutropenia (defined as ANC < 0.5 × 109/L)

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy endpoints	?Depth of ANC count(nadir) in each cycles as compared to baseline?Incidence of Febrile Neutropenia ? (Defined as a rise in axillary temperature to >38.5 °C for a duration of more than 1 hour while having an absolute neutrophil count < 0.5 × 109 /l)?Incidence of severe Neutropenia(defined as ANC < 0.5 × 109/L) ?Time to ANC recovery?Use of Antibiotics for the treatment of Febrile Neutropenia

Trial Locations

Locations (8)

Bharat Cancer Hospital & Research Institute; 🇮🇳 Surat, GUJARAT, India

Cancer Clinic; 🇮🇳 Nagpur, MAHARASHTRA, India

Central India Cancer Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

M.S.Patel Cancer Centre; 🇮🇳 Krishna, India

Mangalam Hospital; 🇮🇳 Rajkot, GUJARAT, India

Medisurge Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Private Clinic; 🇮🇳 Indore, MADHYA PRADESH, India

Shreyas Medical Clinic; 🇮🇳 Vadodara, GUJARAT, India

Bharat Cancer Hospital & Research Institute

🇮🇳Surat, GUJARAT, India

Dr. Tanveer M Maksud

Principal investigator

tanveermaksud@yahoo.com