EUCTR2011-002678-21-CZ进行中（未招募）不适用
A PHASE III, RANDOMIZED, ACTIVE CONTROLLED, ASSESSORBLINDEDSTUDY OF SAFETY AND EFFICACY OF PEGYLATED APOFILGRASTIM VERSUS US AND EU LICENSED NEULASTA® IN SUBJECTS WITH STAGE IIA, IIB OR IIIA BREAST CANCER RECEIVING TAC ANTICANCER CHEMOTHERAPY IN ADJUVANT SETTING
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Apotex Inc
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
研究者
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