EUCTR2012-005161-12-LV进行中（未招募）1 期
A multi-country, multicenter, randomized, open-label, parallel group study to assess the efficacy and safety of Docecal compared with Taxotere®
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 235
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
- •Only patients to whom all of the following conditions apply will be included in the study:
- •1.Signed informed consent.
- •2.Women 18 years or older with histologically confirmed adenocarcinoma of the breast and:
- •a.disease progression after one prior anthracycline chemotherapy regimen for locally advanced or metastatic breast cancer, or
- •b.disease progression during or within 12 months of completing an adjuvant or neoadjuvant anthracycline chemotherapy regimen for locally advanced or metastatic breast cancer.
- •3.Prior chemotherapy completed at least 3 weeks before randomization (with the exception of oral cyclophosphamide [2 weeks] and nitrosureas or mitomycin [6 weeks]). Prior hormonal therapy in the adjuvant and/or metastatic setting is allowed if completed immediately before study entry.
- •4.Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions). Measurable tumour lesions are defined as those with a minimum size of 10 mm by CT scan (or no less than twice the slice thickness for scanners with slice thickness > 5 mm). To be considered pathologically enlarged and measurable, a lymph node must be = 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm).
- •5.Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •6.Adequate haematological, hepatic and renal function defined as:
- •a.Neutrophils = 1.5 × 109/L,
- •b.Platelets = 100 × 109/L,
- •c.Total serum bilirubin = 1 UNL ,
- •d.ASAT and ALAT = 2.5 UNL,
- •e.Alkaline phosphatase = 5 UNL,
- •Patients with ASAT and/or ALAT >1.5 UNL associated with alkaline phosphatase > 2.5 UNL are not eligible for the study.
- •f.Serum creatinine = 2 mg/dL.
- •7.Negative urine pregnancy test for female patients of childbearing potential.
- •8.Women of childbearing potential must agree to use adequate method of contraception for the duration of study treatment and for 6 months after the last dose of study drug.
- •9.Ability and willingness of the patient to follow all requirements of the study 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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Patients to whom any of the following conditions apply must be excluded from the study:
- •1.Known brain metastases/leptomeningeal involvement.
- •2.History of hypersensitivity reaction to products containing docetaxel, polysorbate 80 or XMeNa.
- •3.Definite contraindications for the use of dexamethasone: hypersensitivity to any component of dexamethasone drug formulation, severe infectious diseases.
- •4.History of significant neurologic or psychiatric disorders including dementia or seizures.
- •5.History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma.
- •6.Peripheral neuropathy of Grade 2 or higher (NCI-CTCAE, Version 4.0) at randomization.
- •7.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •8.Concurrent treatment with any other anti-cancer therapy.
- •9.Prior treatment with taxanes, bone marrow transplantation or stem-cell support.
- •10.Radiotherapy within 4 weeks prior to screening.
- •11.Surgery within 2 weeks prior to screening.
- •12.Participation in other clinical trial with any investigational drug within 30 days prior to enrolment or during participation of the current study.
- •13.Pregnant or lactating women.
- •14.Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of study drugs.
研究者
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