EUCTR2006-002860-25-LT进行中（未招募）不适用
A multicenter single arm phase II trial of trastuzumab (Herceptin®) continuation 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 120 人开始时间: 2006年11月17日最近更新:
适应症
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
- 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
- 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 or CISH.
- •6.Adjuvant treatment with trastuzumab and/or anthracyclines is allowed.
- •7. 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, cyclophosphamide, methotrexate, fluorouracil.
- •Trastuzumab may have been continued as monotherapy in the first-line setting if the allowed first-line chemotherapy was discontinued earlier.
- •8.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. List of the allowed drugs for the 2nd-line chemotherapy are detailed in Appendix 1.
- •9.Treatment free interval of trastuzumab between 1st-line and 2nd-line administration is a maximum of 6 weeks.
- •10.At least 4 weeks since major surgery with full recovery.
- •11.At least 4 weeks since radiotherapy with full recovery.
- •12.Complete radiology and tumor measurement work up within 3 weeks prior to randomization.
- •13.Laboratory: neutrophils count = 1,5 x 109/L, platelet = 100 x 109/L, bilirubin <= 2 x the upper limit of normal for the institution (ULN), SGOT/SGPT <= 2,5 x ULN or < 5 x ULN for patients with liver metastases, creatinine <=2.0 mg/dl (within 3 weeks prior to randomization).
- •14.Left ventricular ejection fraction (LVEF) by cardiac ultrasound or MUGA of >= 50% within 3 weeks prior to randomization.
- •15.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, but other than hormonal method to avoid pregnancy during the study.
- •16.ECOG performance status <= 2 and life expectancy >= 12 weeks (see Appendix 2)
- •17.Patients must be accessible for treatment and follow-up.
- •18.Patients entering the trial must be treated and followed at the participating center.
- •* Ad 1st-line therapy: Schedule and dose as investigators’ opinion in the best interest of the patients. Trastuzumab in combination with either of taxanes is considered as standard 1st-line therapy. Anthracyclines are not allowed in this setting.
- •** Trastuzumab has to be given for at least 12 weeks.
- •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.
- •2.Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive or replacement therapy) is not allowed at study entry.
- •3. Anthracyclines in combination with trastuzumab as a part of 1st-line treatment or planned anthracycline administration as 2nd-line chemotherapy.
- •4.Known anamnestic history (or present condition) of brain metastases (including parenchymal and leptomeningeal 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 treatment indicating discontinuation of Herceptin® administration.
- •8.Serious rest dyspnoe in connection with the advanced malignant process claiming supportive oxygen therapy.
- •9.Pleural effusion.
- •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
相似试验
招募中
2 期
Phase II, multicenter, open-label study of Trastuzumab derxtecan in patients with HER2-expressing recurrent and or metastatic salivary gland carcinomaHER2-expressing recurrent and/or metastatic salivary gland carcinomaHER2-expressing, salivary gland carcinoma, recurrent and/or metastaticJPRN-jRCT2011210017Hirotoshi Akita52
进行中（未招募）
1 期
Trastuzumab deruxtecan for subjects with HER2-mutated metastatic NSCLCHER2-mutated metastatic Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000004864EUCTR2020-003427-42-FRDaiichi Sankyo, Inc.150
进行中（未招募）
1 期
Trastuzumab deruxtecan for subjects with HER2-mutated metastatic NSCLCHER2-mutated metastatic Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: LLTClassification code 10064049Term: Lung adenocarcinoma metastaticSystem Organ Class: 100000004864EUCTR2020-003427-42-ITDAIICHI SANKYO INC.150
进行中（未招募）
2 期
Trastuzumab deruxtecan for subjects with HER2-mutated metastatic NSCLCon-Small Cell Lung CancerJPRN-jRCT2061200038Inoguchi Akihiro150
进行中（未招募）
1 期
Trastuzumab deruxtecan for subjects with HER2-mutated metastatic NSCLCHER2-mutated metastatic Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000004864EUCTR2020-003427-42-ESDaiichi Sankyo, Inc.150