EUCTR2009-017219-13-DE进行中（未招募）不适用
Adjunction with Capecitabin, Lapatinib and Vinorelbin to treat patients with HER2/new-positive, advanced or metastized breast cancer after failure of Trastuzumab
Deutsche Krebsgesellschaft Sponsor GmbH0 个研究点开始时间: 2010年5月19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
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 informed consent
- •2. patient age = 18 years
- •3. willingness and ability to comply with study protocol
- •4. secured contraception for sexual active females with childbearing potential respectively secured postmenopausal state (at least two years of amenorrhea or confirmed by hormonal state). The contraception must be continued for 6 months after the end of treatment.
- •5. histologically secured adenocarcinoma in breast (unilateral or bilateral)
- •6. Status: locally advanced or metastized
- •7. HER2/new-Status positive (3+ ICH or FISH/CISH positive)
- •8. at least one measurable lesion according to RECIST 1.1 criteria
- •9. first or second chemotherapy after diagnosis of metastasis
- •10. existing indication for therapy with Lapatinib, i.e.
- •2nd line after Trastuzumab-therapy or
- •1st line if adjuvant Trastuzumab-therapy < 12 months ago
- •Anthracycline- and Taxan-therapy in adjuvant/palliative indication is not obligatory
- •State of health
- •11. good general state of health (ECOG Performance Status 0-1), symptomatic regarding tumor disease
- •12. no congestive heart insufficiency symptoms, respectively no suspicion of congestive heart insufficiency, LVEF at timepoint of enrolment at least55%
- •13. adequate liver and renal function, defined as:
- •- albumin > 2,5 g/dl,
- •- serous bilirubin = 2 mg/dl or up to triple upper normal value under liver metastasis
- •- AST and ALT up to 2,5-fold upper normal value, respectively fivefold upper normal value under documented liver metastasis
- •- serous creatinine in normal range or creatinin-clearance > 60 ml/min (according to Cockroft/Gault formula) if serous creatinine is out of range
- •14. adequate hematopoietic Funktion:
- •- neutrophile granulocytes > 1500/ µl
- •- haemoglobin > 10g/dl
- •- thrombocytes > 100 000/ µl
- •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. pregnant or breastfeeding females. Urine or serum pregnancy test prior to treatment start is indicated for all females with childbearing potential.
- •2. synchronous participation in another clinical study, synchronous treatment with a product without marketing authorization. The participation in a former clinical study does not conflict with a registration as long as the last medication with another study drug was more than four weeks ago.
- •3. asymptomatic regarding tumor disease.
- •Permitted former or ongoing antineoplastic therapies
- •4. former treatment with Lapatinib, Capecitabin or Vinorelbin
- •5. essential or intended treatment with other cytostatic drugs or anti-hormone therapy.
- •Pre-existing conditions
- •6. significant injury, major surgical interventions or open biopsies during the past 28 days prior to enrolment or during the study period, not completely healed traumata after surgery
- •7. indication for cardiovascular diseases in 2-D echocardiograph or electrocardiogram, particularly myocardial insufficiency, unstable angina pactoris or arrhythmia
- •8. relevant vascular diseases or cardiovascular system diseases (e.g. arterial or venous thrombosis, myocardial infarct, ischaemic seizure, angioplstica or stents or cerebrovaskular events) during the past six months
- •9. every disease, which might have an influence on resorption or kinetics, i.a.: Malabsorption syndrome, significant influence on gastrointestinal function or not minimal surgical interventions in gastrointestinal tract, colitis ulcerosa, ileus etc.
- •10. synchronous treatment with virostatic drugs of Sorivudin-type or aminoglycoside
- •11. concomitant medication with products inducing CYP3A (e.g. Rifabutin, Rifampicin, Clarithromycin, Ketoconazol, Itroconazol, Ritinavir, Telithromycin, Erythromycin, Verapamil, Diltiazem, etc.)
- •12. concomitent medication with Allopurinol (interaction with Capecitabin)
- •13. other malignant tumour (beside basal cell carcinoma and cervical carcinoma in situ) in medical history. The patient can be enrolled regardless being in complete remission for 5 years.
- •14. concomitant diseases or other circumstances e.g. in family or psychologic, that might have an influence on patient's ability to participate, the efficacy of the products or patients safety.
- •Contraindication against products of antineoplastic combination therapy
- •15. known dihydropyrimidine dehydrogenase deficiency or former serious reaction under fluoropyrimidine administration (with or withot established dihydropyrimidine dehydrogenase deficiency)
- •16. anaphylaxis or allergy against one of the agents or the excipients contained in the product.
- •17. allergy against CHO-cell products or other human antibodies
- •18. known anaphylaxis of acute type or delayed type against agants chemically related with Capecitabin, Vinorelbin or Lapatinib.
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