EUCTR2006-002860-25-LV进行中（未招募）不适用
A multicenter randomized phase III trial to compare trastuzumab (Herceptin®) continuation or discontinuation in combination with 2nd-line chemotherapies after progression on a 1st-line chemotherapy combined with trastuzumab in patients with HER2 positive metastatic breast cancer (Treatment Beyond Progression, TBP) - PANDORA
Roche Hungary Ltd.0 个研究点目标入组 274 人开始时间: 2007年4月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 274
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
- •1.Written and signed informed consent prior to beginning specific protocol procedures showing the patients’ willingness and awareness to participate in the trial and comply with its proceedings.
- •2.Female patients
- •3.Age >18 years.
- •4.Pathologically confirmed and documented metastatic breast cancer.
- •5.Documented HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (IHC 3+) and/or genamplification detected by FISH.
- •6.Disease progression during or after a previous 1st-line chemotherapy* plus trastuzumab treatment as follows:
- •Either of taxanes (docetaxel or paclitaxel) + trastuzumab given as 1st-line therapy for palliation
- •Other allowed chemotherapy drugs combined with trastuzumab in 1st-line setting: vinorelbine, gemcitabine, capecitabine, platinum compounds, cycylophosphamide, methotrexate, fluorouracil.
- •7.Patients are scheduled to receive an effective 2nd-line chemotherapy as per standard medication care. Schedule and dose as investigators’ opinion in the best interest of the patients.
- •8.Treatment free interval of trastuzumab between 1st-line and 2nd-line administration is a maximum of 6 weeks.
- •9.At least 4 weeks since major surgery with full recovery.
- •10.At least 4 weeks since radiotherapy with full recovery.
- •11.Complete radiology and tumor measurement work up within 5 weeks prior to randomization.
- •12.Laboratory: neutrophils count = 1,5 x 109/L, platelet = 100 x 109/L, bilirubin =or< 2 x the upper limit of normal for the institution (ULN), SGOT/SGPT =or<2,5 x ULN or < 5 x ULN for patients with liver metastases, creatinine =or<2.0 mg/dl (within 3 weeks prior to randomization).
- •13.Left ventricular ejection fraction (LVEF) by cardiac ultrasound or MUGA of =50% within 3 weeks prior to randomization.
- •14.If of childbearing potential, pregnancy test – either urine or serum test - is negative within 1 week prior to randomization. In addition the patient agrees to use an effective method to avoid pregnancy during the study.
- •15.ECOG performance status =or<2 and life expectancy =12 weeks (see Appendix 2)
- •16.Patients must be accessible for treatment and follow-up.
- •17.Patients entering the trial must be treated and followed at the participating center.
- •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
- •1.Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- •2.Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive or replacement therapy).
- •3.Anthracyclines as a part of the previous 1st-line chemotherapy or the planned 2nd-line chemotherapy.
- •4.Known anamnestic history (or present condition) of parenchymal brain metastases.
- •5.Prior history of myocardial infarction within the previous 6 months.
- •6.Unstable angina pectoris, uncontrolled arrhythmia and cardiac insufficiency (NYHA Class III-IV) at the time of inclusion.
- •7.Cardiac toxicity during the previous 1st-line chemotherapy plus trastuzumab treatment indicating discontinuation of Herceptin® administration.
- •8.Serious rest dyspnoe in connection with the advanced malignant process claiming supportive oxygen therapy.
- •9.Pleural effusion, unless clinically controllable.
- •10.Serious intercurrent medical conditions that may interfere with the planned treatment (including AIDS, serious active infection, CNS disease, psychiatric illness).
- •11.History of other malignancy within the last 5 years, which could affect the diagnosis or assessment of breast cancer.
- •12.Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- •13.Pregnant or nursing women.
- •14.Patients who in opinion of investigator are ineligible for 2nd-line chemotherapy.
研究者
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