EUCTR2008-004013-94-GB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 - SHERsig
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 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.
- •10. Oral or parenteral anticoagulation within 7 days prior to the baseline biopsy and/or coagulation profile outside the normal laboratory range within 48 hrs prior to the baseline biopsy.
- •11. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- •12. Concurrent immunotherapy or anticancer hormonal therapy.
- •13. Inadequate bone marrow function: ANC < 1.5 x 109/L, platelet count < 100 x 109/L or Hb < 9 g/dL.
- •14. Inadequate renal function: serum creatinine > 2.0 mg/dL or 177 µmol/L.
- •15. Inadequate liver function:
- •serum (total) bilirubin > 1.5 ULN,
- •AST and ALT > 3 x ULN (>6 x ULN for patients with liver metastases),
- •AST or ALT > 3 x ULN concurrent with serum alkaline phosphatase levels > 6 x ULN at baseline.
- •Prior or Concomitant Conditions
- •16. Serious concurrent disease which could affect compliance with the protocol or interpretation of results, including, but not limited to:
- •Known bleeding diastheses
- •Co-morbid condition which does not permit cessation of anti-platelet therapy (such as clopidigrel, aspirin) for 7 days before and after serial core biopsies
- •Existing peripheral neuropathy NCI grade > 2 from any cause
- •Active infection requiring antibiotics
- •Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg)
- •Clinically significant cardiovascular disease: Cerebrovascular accident / stroke (= 6 months prior to registration), myocardial infarction (= 6 months prior to registration), unstable angina, New York Heart Association (NYHA) Class 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- •Dyspnoea at rest requiring supportive oxygen therapy or with significant pleural effusions
- •Patients requiring chronic daily treatment with corticosteroids (dose of >10 mg/day methylprednisolone equivalent) (excluding inhaled steroids)
- •17. Cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab.
- •18. Left ventricular ejection fraction (LVEF) of < 50% by echocardiogram or MUGA.
- •19. Evidence of any other serious intercurrent disease, metabolic or psychological dysfunction, physical examination finding, or clini
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