Febrile neutropenia in breast cancer patients undergoing TAC chemotherapy MedDRA version: 14.1 Level: PT Classification code 10016288 Term: Febrile neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Pegylated Apo-Filgrastim
Product Code: Pegylated Apo-Filgrastim
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: PEGFILGRASTIM
CAS Number: 208265-92
Sponsors
Apotex Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female, =18 of age, suitable and intended to undergo adjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy. 2. Body weight within 40 and 120 kg 3. Subjects within 60 days of complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS) 4. Stage IIA, IIB or IIIA breast cancer 5. Eastern Cooperative Oncology Group (ECOG) performance status = 2 6. Absolute neutrophil count (ANC) =1,5 x 109/L; platelet count =100 x 109/L 7. Adequate renal (serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1. Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast 2. History of severe hypersensitivity reaction to medications intended to use in this protocol 3. Prior chemotherapy (either adjuvant or neoadjuvant) for this breast cancer 4. History of myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes 5. Immunotherapy, hormonal therapy (e.g. tamoxifen or aromatase inhibitors), Herceptin (trastuzumab) concurrently or within 30 days of screening 6. Concurrent radiation therapy 7. Investigational therapy concurrently or within 30 days of screening 8. Peripheral neuropathy >Grade 1 9. Major organ allograft or condition requiring chronic immunosuppression (i.e. kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who received corneal transplants or cadaver skin or bone transplants are eligible. 10. Serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined acquired immunodeficiency syndrome - AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or central nervous system disorders deemed by the Investigator to be clinically significant, precluding informed consent 11. Active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive 12. History of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix or DCIS) 13. Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate an equivalent efficacy of Pegylated Apo-Filgrastim as compared to each of the commercially available US and EU licensed Neulasta® in patients suffering from early breast cancer and receiving TAC (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in adjuvant setting.;Secondary Objective: • To assess the safety of Pegylated Apo-Filgrastim as compared to that of commercially available US and EU licensed Neulasta® when administered through 6 cycles of TAC anticancer chemotherapy • To assess the potential antigenicity of Pegylated Apo-Filgrastim during the chemotherapy and 30 weeks after the completion of chemotherapy;Primary end point(s): Duration of severe neutropenia (DSN) in cycle 1. Severe neutropenia is defined as occurrence of ANC below 0,5 x 109/L.;Timepoint(s) of evaluation of this end point: D0,D1,D3,D5,D6,D8 and D10-15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • The frequency of grade 3 and 4 severe neutropenia (ANC below 1,0 x 109/L and 0,5 x 109/L, respectively) • The depth of ANC nadir in cycles 1 • The time to the post nadir ANC recovery (ANC =2,0 X 109) in cycle 1 • The rates of Febrile Neutropenia (FN) by cycle and across the cycles. The definition of FN used for the purpose of this protocol will be, single temperature: =38,3°C measured orally or =38,0°C for over 1 hour; neutropenia: ANC <0,5 X 109/L or <1 X 109/L and a predicted decline to =0,5 X 109/L over the next 48 hours. • The ANC-time profile in cycle 1 (The time from the beginning of chemotherapy to the occurrence of the ANC nadir) • The frequency and type of (culture-confirmed) infections • The incidence of i.v. antibiotic therapy and hospitalization • The mobilization of CD34+ cells (in selected centers only) • Incidence, severity and distribution of bone pain • Percentage of scheduled chemotherapy dose that was delivered • Proportion with chemotherapy doses reduced, omitted, or delayed • Number of days of delay of chemotherapy • Occurrence and/or resolution of chemotherapy-induced mucositis Safety endpoints • Incidence of adverse events (all severe and serious) classified by system organ class, preferred term, severity, and relationship to study medication • Injection site reactions • Vital signs • Presence of antibodies and abnormal clinical laboratory results.;Timepoint(s) of evaluation of this end point: Cycle1: D0,D1,D2,D3,D5,D6,D7,D9 and D8, D10-15 Cycle 2-6:D1,D2,D9±1, W20,W24,W36 and W48 | — |
Countries
Belarus, Bosnia and Herzegovina, Bulgaria, Czech Republic, Egypt, Georgia, Greece, Hungary, Morocco, Poland, Romania, Russian Federation, Serbia, Slovakia, Tunisia, Turkey, Ukraine
Contacts
Public ContactClinical Trials Info
Accelsiors CRO and Consultancy Services
Outcome results
None listed