NCT02768714撤回3 期
A Randomized, Assessor-blind, Parallel Group, Multicentre Phase III Trial to Compare the Efficacy and Safety of Eurofarma's Pegfilgrastim to Neulastim® in Subjects With High Risk Stage II or Stage III / IV Breast Cancer Receiving Chemotherapy.
Eurofarma Laboratorios S.A.0 个研究点开始时间: 2018年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Duration of severe neutropenia (grade 4) in days during chemotherapy cycle 1.
研究概览
简要总结
This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least 180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised (1:1) to receive either Eurofarma's pegfilgrastim (n = 90) or Neulastim (n = 90) in 8 to 10 sites in Brazil. Subjects will undergo a maximum of 4 cycles of myelosuppressive chemotherapy (21 days per cycle).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Males or females ≥ 18 years of age (at the time of signing consent)
- •Breast cancer high-risk Stage II, or Stage III, or Stage IV (classification according to American Joint Committee on Cancer)
- •Eligible to receive 4 cycles of docetaxel and doxorubicin combination CTX for the treatment of high-risk stage II, III, or IV breast cancer
- •ECOG performance status ≤ 2
- •Adequate bone marrow function:
- •Leucocyte count < 50 x 109/L
- •ANC ≥ 1.5 x 109/L
- •Platelet count ≥ 100 x 109/L
- •Haemoglobin ≥ 10 x g/dL
- •Left Ventricular Ejection Fraction (LVEF) ≥ 50% by echocardiography or equivalent method (e.g. Multi Gated Acquisition scan) within 4 weeks prior to administration of the first dose of trial medication
- •Alanine aminotransferase and aspartate aminotransferase < 2.5 x upper limit of normal (ULN), alkaline phosphatase < 5 x ULN
- •Total bilirubin ≤ ULN
- •Creatinine ≤ 1.5 x ULN
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of trial treatment and agree to use highly effective contraception (e.g. hormonal contraception or intra-uterine device [which should be established prior to the start of the trial], plus usage by at least 1 of the partners of an additional spermicide-containing barrier method of contraception) from 2 weeks prior to administration of the first dose of trial medication until trial completion, and for 30 days after the last dose of trial drug
- •Female subjects of non-childbearing potential must have a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. A male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from 2 weeks prior to administration of the first dose of trial medication until trial completion, and for 30 days after the last dose of trial drug
- •Able to comply with the trial Protocol.
排除标准
- •Severe chronic neutropenia
- •History of chronic myeloid leukaemia or myelodysplastic syndrome
- •History of sickle cell disease
- •Previous or concurrent malignancy except non-invasive non-melanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumour treated curatively, and without evidence of recurrence for at least 10 years prior to trial entry
- •Active uncontrolled infection
- •Known human immunodeficiency virus seropositivity; active hepatitis B or hepatitis C at the Screening Visit
- •Clinically significant impairment of LVEF
- •Severe valvular heart disease, myocardial infarction, heart failure, unstable angina pectoris, uncontrolled hypertension, or uncontrolled arrhythmias within 6 months of the Screening Visit
- •Significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent
- •Concurrent or prior radiotherapy within 4 weeks of the Screening Visit
- •Tumour surgery within 4 weeks prior to administration of the first dose of trial medication
- •Concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
- •Concurrent prophylactic antibiotics or antibiotic treatment within 72 hours before CTX
- •Prior bone marrow or stem cell transplant
- •Previous therapy with any recombinant human granulocyte colony stimulating factor (G CSF) product
- •Known hypersensitivity to docetaxel, doxorubicin, pegfilgrastim, filgrastim, Escherichia coli proteins, or any of the excipients used in the trial medication
- •Treatment with lithium at randomization
- •Known controlled drug addiction, including alcoholism
- •Participation in a clinical trial within 30 days prior to the Screening Visit
- •Pregnant or nursing women, women planning to become pregnant, or women of childbearing potential who do not agree to use highly effective contraception (e.g. hormonal contraception or intra-uterine device [which should be established prior to the start of the trial], plus usage by at least 1 of the partners of an additional spermicide-containing barrier method of contraception) from 2 weeks prior to administration of the first dose of trial medication until trial completion and for 30 days after the last dose of trial drug
- •Male subjects with a female partner of childbearing potential who have not had a prior vasectomy and do not agree to use highly effective contraception from 2 weeks prior to administration of the first dose of trial medication until trial completion and for 30 days after the last dose of trial drug
- •Any severe concurrent disease or condition, which in the judgment of the Investigator would make the subject inappropriate for trial participation.
- •Peripheral neuropathy (sensory/motor) Grade 2 or higher (CTCAE, Version 4.03)
- •Chronic use of corticosteroids.
研究组 & 干预措施
Eurofarma's pegfilgrastim
Experimental
A single 6 mg dose on Day 2 of each chemotherapy cycle of Eurofarma's pegfilgrastim (subcutaneous injection)
干预措施: Eurofarma's pegfilgrastim (Drug)
Neulastim
Active Comparator
A single 6 mg dose on Day 2 of each chemotherapy cycle of Neulastim (subcutaneous injection)
干预措施: Neulastim (Drug)
结局指标
主要结局
Duration of severe neutropenia (grade 4) in days during chemotherapy cycle 1.
时间窗: Within the 21 Days of the first chemotherapy cycle
次要结局
- Duration of severe neutropenia (grade 4) in days during chemotherapy Cycles 2, 3, and 4(Four months)
- Incidence of febril neutropenia during chemotherapy cycles 1, 2, 3, and 4 and across all chemotherapy cycles.(Four months)
- Incidence of infections during chemotherapy cycles 1, 2, 3, and 4 and for all chemotherapy cycles combined.(Four months)
- Use of IV antibiotics to treat febril neutropenia or associated infections(Four months)
- Overall survival(one year after the last chemotherapy cycle)
研究者
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