EUCTR2008-002819-40-ES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
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
- 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
- 性别
- All
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 gene-amplified by FISH) based on local laboratory assay results
- •3. No prior chemotherapy for MBC. (Hormonal therapy is allowed.)
- •4. Measurable disease per RECIST
- •Measurable disease is defined as at least one lesion with a longest diameter of ?20 mm (?10 mm on a spiral computed tomography [CT] scan).
- •5. Tumor blocks or 11 unstained slides available for confirmatory central laboratory HER2 testing
- •b. General Criteria
- •6. Age ?18 years
- •7. LVEF ?50% at baseline (or ?4 weeks from baseline) as determined by either ECHO or MUGA
- •8. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
- •9. Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization:
- •Absolute neutrophil count >1500 cells/mm[3]
- •Platelet count > 100,000 cells/mm[3]
- •Hemoglobin > 9.0 g/dL
- •Total bilirubin ? upper limit of normal (ULN)
- •SGOT (AST) and/or SGPT (ALT) ?1.5 ×ULN
- •Alkaline phosphatase ? 2.5 ×ULN
- •Patients with hepatic and/or bone metastases: alkaline phosphatase ?5 ×ULN
- •Creatinine < 1.5 × ULN
- •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 ×ULN (unless on therapeutic coagulation or due to a coagulant)
- •10. For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use 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
- •2. An interval of <12 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. 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 carcinoma in situ of the cervix or basal cell carcinoma
- •7. Previous radiotherapy for the treatment of MBC is not allowed if:
- •More than 25% of marrow-bearing bone has been irradiated.
- •The last fraction of radiotherapy has been administered within 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 3 months of the first study treatment. CT or magnetic resonance imaging (MRI) scan of the brain is mandatory (within 4 weeks of 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 > 360 mg/m[2]
- •Epirubicin > 720 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 360 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 of randomization
- •13. LVEF below 50% within 28 days of randomization
- •14. History of decreased LVEF or symptomatic CHF with previous adjuvant trastuzumab treatment
- •15. Cardiac troponin I ? 0.2 ng/mL within 28 days of 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 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
- •19. Current pregnancy or lactation
- •20. History of receiving any investigational treatment within 28 days of randomization
- •21. Current known infection with HIV, active hepatitis B and/or hepatitis C virus
- •22. History of intolerance (including Grade 3?4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel
- •23. Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80
- •24. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
研究者
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