STUDY OF SAFETY AND EFFICACY OF PEGYLATED APOFILGRASTIM VERSUS US AND EU LICENSED NEULASTA® IN PATIENTS WITH BREAST CANCER
- Conditions
- Febrile neutropenia in breast cancer patients undergoing TAC chemotherapyMedDRA version: 16.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-002678-21-CZ
- Lead Sponsor
- Apotex Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
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 <1,5 x upper limit of normal (ULN)) and hepatic function (bilirubin < ULN, transaminases and alkaline phosphatase (AP) <1,5 x ULN)
8. Normal cardiac function evidenced by a left ventricle ejection fraction (LVEF) =55%
9. No evidence of metastatic disease
10. Baseline bilateral mammography (or other scan to exclude cancer on the contralateral breast)
11. Subjects must not intend to conceive during or shortly after the study. They must be either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control (e.g., hormonal contraceptives, intrauterine device, or spermicide and barrier) and be willing to continue the same method of birth control during the entire course of the study
12. Females of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose of study medication
13. Willing and able to give written informed consent
14. Willing and able to undergo procedures required by this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 545
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate an equivalent efficacy of Pegylated Apo-Filgrastim as<br>compared to each of the commercially available US and EU licensed<br>Neulasta® in patients suffering from early breast cancer and receiving TAC<br>(docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in<br>adjuvant setting.;Secondary Objective: • To assess the safety of Pegylated Apo-Filgrastim as compared to that<br>of commercially available US and EU licensed Neulasta® when administered through 6 cycles of TAC anticancer chemotherapy<br>• 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<br>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 Outcome Measures
Name Time Method