EUCTR2012-004928-38-ES进行中（未招募）1 期
A phase III clinical trial to evaluate patient´s preference of subcutaneous trastuzumab (SC) versus intravenous (IV) administration in patients with HER2 positive Advanced Breast Cancer (ABC) who have received intravenous trastuzumab at least 4 months and without disease progression - ChangHER-SC
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)0 个研究点目标入组 15 人开始时间: 2012年12月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- •11. Woman, 18 years old or upper.
- •2. Patient with advanced breast cancer with HER2 positive histologically confirmed. The criteria for positivity HER2 are:
- •- IHC 3 +
- •- IHQ2 + with FISH / CISH / SISH positive for HER2 amplification (*)
- •- FISH / CISH / SISH positive for HER2 amplification (*)
- •(*) Defined as the ratio of copies of HER-2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER-2/neu> 6, as per local laboratory criteria.
- •3. Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.
- •4. No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.
- •5. Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2.
- •6. Adequate bone marrow function, liver and kidney, as follows:
- •? Bone marrow: ANC ? 1500/mm3 (1.5 x 109 / l), platelets ? 100.000/mm3 (100.0 x 109 / l) and hemoglobin ? 9.0 g / dl.
- •? Liver function: total serum bilirubin ? 1.5 x upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) ? 2.5 × ULN or ? 5.0 x ULN if the elevated transaminases due to liver metastases, and alkaline phosphatase (ALP) ? 5.0 x ULN.
- •? Renal function: serum creatinine 1.5 x ULN ?.
- •7. Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).
- •8. The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.
- •9. The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.
- •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 195
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 195
排除标准
- •1. Patients with no advanced breast cancer.
- •2. Breast cancer patients with tumors HER2-negative.
- •3. The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.
- •4. The patient has uncontrolled brain metastases.
- •5. Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.
- •6. Known hypersensitivity to trastuzumab or to any of its components.
- •7. Patients with severe dyspnea at rest or requiring supplemental oxygen.
- •8. Heart disease or serious medical pathological prevent trastuzumab administration: documented history of CHF, high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.
- •9. Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).
- •10. The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.
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