Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gema Biotech S.A.
• Collaborator: QUID Quality in Drugs and Devices Latin American Consulting SRL
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Female patients aged 18 to 70 years old.

• Patients diagnosed having high risk stage 2 or stage 3 or 4 of breast cancer (by histopathological or cytological diagnosis) and need neoadjuvant, adjuvant chemotherapy, or with metastatic disease.

• A priori has been decided to be treated with Peg-Filgrastim and subjects eligible for Peg-Filgrastim therapy according to indications and clinical use in the product monograph

• Patients scheduled to receive 4 or 6 cycles of chemotherapy (Taxane combinations) with prophylactic Peg-Filgrastim at 3 weeks interval. Monoclonal Antibodies in addition to Taxane regimens are permitted.

• Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1

• Eastern Cooperative Oncology Group - ECOG Performance Status 0, 1 or 2 as determined on Day 1 or up to -3 of Cycle 1 prior to administration of chemotherapy

• Patients must have adequate organ function including the following:

1. Adequate bone marrow functions, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by Hb ≥9,5 g/dl (transfusion permitted to be included in the trial ),WBC (white blood cell) ≥3,5 x 109/l, Absolute neutrophil count (ANC) ≥1.5 x 109/l, Platelets ≥95 x 109/l;

2. Adequate renal and hepatic function, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and defined as follows,

1. Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless elevation is known to be due to Gilbert's disease), Subjects must also meet one of the following criteria:

1. Alkaline phosphatase within normal reference range and both AST (aspartate aminotransferase) and ALT (alanine aminotransferase) >2.5 x ULN; or

2. Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or

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

2. Renal: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≤ 60 ml/min (calculated according to the Cockcroft and Gault formula)

• Patients of child-bearing potential must have a negative pregnancy test within 3 days prior to the first dose of chemotherapy and at day 1 or up to -3 days of each Cycle) and use at least one form of contraception as approved by the investigator during the study.

• Life expectancy >6 months

Exclusion Criteria:

Safety of treatment dependent criteria:

• Presence of any serious concomitant systemic disorders incompatible with the administration of filgrastim, Peg-Filgrastim or any systemic disease that can influence the patient's safety according to doctor's diagnosis.

• History of hypersensitivity to Peg-Filgrastim, filgrastim or E.coli derived proteins.

• Serious local infection or active systemic infection within 10 days prior to enrollment or patients who have taken antibiotics within the previous 10 days

• Pregnant or breast-feeding patients

• Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)

• Known bleeding disorder

• Patient known to have HIV, Hepatitis B, Hepatitis C or who have a positive serology for HIV, Hepatitis B or Hepatitis C at screening

• History or presence of sickle cell disease

• Concurrent or prior radiotherapy within four weeks of randomization

Criteria dependent on compliance with study procedures, or the evaluation of the response:

• Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)

• Treatment with certain other agents to treat the malignant disease

• Known drug addiction, including alcoholism

• Treatment with any investigational product within 30 days prior to study drug administration

• Concurrent prophylactic antibiotics

• Previous participation in this study.

• Already involved in another trial.

• History of bone marrow or stem cell transplantation.

• Previous therapy should not have included G-CSF (granulocyte-colony stimulating factor)

Previous participation in this study: Subjects who are considered screening failures are allowed to be re-screened, except if have started chemotherapy. In case of re-screening the following assessments and evaluations do not have to be repeated: Demographics, Medical history, HIV, Hepatitis B and C serology.