EUCTR2008-002819-40-GB进行中（未招募）1 期
A randomized, multicenter, Phase II study of the efficacy and safety of trastuzumab-MCC-DM1 vs. trastuzumab (Herceptin®) and docetaxel (Taxotere®) in patients with metastatic HER2-positive breast cancer who have not received prior chemotherapy for metastatic disease
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
入选标准
- •a. Disease-Specific Criteria
- •1. Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy. Patients with locally advanced disease must have recurrent or progressive disease after failing initial attempts at local control. The disease must be considered to be unresectable.
- •2. HER2-positive (IHC 3+ or FISH-positive) based on local laboratory assay results
- •3. No prior chemotherapy for their MBC. (Hormonal therapy is allowed.)
- •4. Measurable disease per modified RECIST
- •Patients should have at least one target lesion =2cm on conventional CT scan or = 1cm on a spinal CT scan.
- •5. Tumor blocks or 11 unstained slides available for confirmatory central laboratory HER2 testing
- •b. General Criteria
- •6. Age =18 years
- •7. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
- •8. Adequate organ function, evidenced by the following laboratory results within approximately 21 days prior to randomization:
- •9. Absolute neutrophil count >1500 cells/mm[3]
- •Platelet count > 100,000 cells/mm[3]
- •Hemoglobin > 9.0 g/dL
- •Patients are allowed to be transfused with red blood cells to obtain this level
- •Total bilirubin = 1.5 x the upper limit of normal (ULN)
- •SGOT (AST), SGPT (ALT) and alkaline phophatase =2.5 ×ULN
- •following exception:
- •Patients with hepatic and/or bone metastases: alkaline phosphatase =5 ×ULN
- •Serum Creatinine < 1.5 × ULN
- •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 ×ULN (unless on therapeutic anticoagulation or due a lupus anticoagulant)
- •10. For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study. Specific country requirements will be followed (e.g., in the United Kingdom, women of childbearing potential and male subjects and their partners of childbearing potential must use two methods of contraception [one of which must be a barrier method] for the duration of the study).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Cancer-Related Criteria
- •1. History of any chemotherapy for MBC
- •Prior hormonal therapy is allowed
- •2. An interval of <6 months from the completion of cytotoxic chemotherapy (excluding hormonal therapy) in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis. Patients who progress on or within 12 months on single-agent trastuzumab will be considered eligible (unless trastuzumab has been given = 21 days prior to randomization).
- •3. Trastuzumab = 21 days prior to randomization
- •4. Hormone therapy < 7 days prior to randomization
- •5. Current peripheral neuropathy of Grade =3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0
- •6. History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned.
- •7. Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if:
- •More than 25% of marrow-bearing bone has been irradiated.
- •The last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.
- •8. Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomisation. CT or magnetic resonance imaging (MRI) scan of the brain is mandatory (within approximately 28 days prior to randomization) in cases of clinical suspicion of brain metastases or in a patient with any prior history of brain metastases.
- •9. History of exposure to the following cumulative doses of anthracyclines:
- •Doxorubicin or liposomal doxorubicin > 500 mg/m[2]
- •Epirubicin > 900 mg/m[2]
- •Mitoxantrone > 120mg/m[2] and idarubicin > 90 mg/m[2]
- •If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 500 mg/m[2] of doxorubicin.
- •b. Cardiopulmonary Function
- •10. Current unstable angina
- •11. History of symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] classes II-IV), or ventricular arrhythmia requiring treatment
- •12. History of myocardial infarction within 6 months prior to randomization
- •13. LVEF below 50% within approximately 28 days prior to randomization
- •14. History of decrease in LVEF <40% or symptomatic CHF with previous adjuvant trastuzumab treatment
- •15. Cardiac troponin I = 0.2 ng/mL within approximately 28 days prior to randomization
- •16. Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy
- •General Criteria
- •17. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures)
- •18. Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation o
研究者
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