EUCTR2008-004013-94-SE
进行中（未招募）
不适用
A prospective Phase II study to evaluate alterations in molecular biomarkers in HER2-positive metastatic breast cancer together with assessment of trastuzumab use beyond progression after initial exposure to trastuzumab-taxane based treatment - SHERsig
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Treatment of patients with HER2-positive metastatic breast cancer
- 发起方
- F. Hoffmann-La Roche Ltd.
- 入组人数
- 50
- 状态
- 进行中（未招募）
- 最后更新
- 13年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Written and signed informed consent prior to beginning protocol\-specific procedures.
- •2\. Female patients age \=18 years.
- •3\. Evaluable with or without measurable metastatic breast cancer and at least one metastatic lesion which is amenable to multiple core biopsies.
- •4\. HER2\-positive metastatic lesion, defined as IHC3\+ and/or ISH positive (FISH, CISH or SISH), as confirmed by the central laboratory testing.
- •5\. All tumor biopsy material can be made available for central laboratory testing.
- •6\. ECOG performance status \= 2\.
- •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
排除标准
- •Prior or Current Treatments
- •1\. Prior chemotherapy for metastatic disease.
- •2\. Prior trastuzumab\-based therapy for metastatic breast cancer.
- •3\. Prior therapy with capecitabine.
- •4\. Prior adjuvant/neoadjuvant trastuzumab, or adjuvant bevacizumab or tyrosine kinase inhibitor (TKI) completed \<6 months prior to first study treatment.
- •5\. Prior doxorubicin \>360 mg/m2 or epirubicin 720 mg/m2 or equivalent.
- •6\. Prior adjuvant taxane completed \<12 months prior to first study treatment.
- •7\. Biopsy of metastatic or breast lesion with fine needle aspiration only.
- •8\. CNS disease as the only site of metastatic disease.
- •9\. Use of immunotherapy or biological anticancer therapy within 21 days prior to study entry.
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
A prospective Phase II study to evaluate alterations in molecular biomarkers in HER2-positive metastatic breast cancer together with assessment of trastuzumab use beyond progression after initial exposure to trastuzumab-taxane based treatment - SHERsigEUCTR2008-004013-94-GBF. Hoffmann-La Roche Ltd.50
进行中（未招募）
不适用
Estudio fase II prospectivo para evaluar alteraciones en biomarcadores moleculares y la administración de trastuzumab tras progresión a la exposición inicial de trastuzumab-taxano en pacientes diagnosticadas de cáncer de mama metastásico HER2-positivoA prospective Phase II study to evaluate alterations in molecular biomarkers in HER2-positive metastatic breast cancer together with assessment of trastuzumab use beyond progression after initial exposure to trastuzumab-taxane based treatment - SHERsigTratamiento de pacientes con cáncer de mama metastásico HER2-positivo Treatment of patients with HER2-positive metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerEUCTR2008-004013-94-ESF. Hoffmann-La Roche Ltd.50
招募中
2 期
A phase II trial of adjuvant chemo-radiation followed by chemotherapy for patients with newly diagnosed endometrial carcinoma at high-risk of relapseACTRN12605000561684Peter MacCallum Cancer Centre40
进行中（未招募）
不适用
An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on GlomerularFiltration Rate (GFR) in Subjects with Type 2 Diabetes who have Inadequate Glycemicand Blood Pressure (BP) ControlPharmacogenetics Blood Sample Amendment 01 (v1.0, dated 24-Jul-2009)EUCTR2009-010221-39-NLBristol Myers Squibb International Corporation150
进行中（未招募）
不适用
A clinical study evaluating the efficacy of topical cromoglicate solution compared to placeboin the treatment of mastocytosismastocytosisMedDRA version: 15.0Level: PTClassification code 10012812Term: Diffuse cutaneous mastocytosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 15.0Level: LLTClassification code 10056452Term: Indolent systemic mastocytosisSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2011-006275-20-DEEO Pharma A/S