Status:
UNKNOWN
Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.
Lead Sponsor:
Gema Biotech S.A.
Collaborating Sponsors:
QUID Quality in Drugs and Devices Latin American Consulting SRL
Conditions:
Breast Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 asse...
Detailed Description
Eligible patients will be scheduled to receive a chemotherapy regimen with risk of febrile neutropenia ≥20%. Study drug will be administered more than 24 hours after completion of chemotherapy and eve...
Eligibility Criteria
Inclusion
- 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:
- 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;
- 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,
- 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:
- Alkaline phosphatase within normal reference range and both AST (aspartate aminotransferase) and ALT (alanine aminotransferase) \>2.5 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;
- 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
- 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.
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03404752
Start Date
August 1 2015
End Date
December 1 2018
Last Update
January 19 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
COIBA
Buenos Aires, Bs As, Argentina