EUCTR2013-000551-41-NL进行中（未招募）不适用
Towards patient tailored cancer treatment supported by molecular imagingIMPACT: IMaging PAtients for Cancer drug selecTion – Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first-line systemic therapy.
- •2. Patient with non-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation which may include:
- •no recent (< 2 weeks prior to screening visit) significant worsening of MBC related signs and symptoms according to patient history.
- •in case of liver metastases: no significant (>50%) increase in liver function tests ASAT and ALAT in 2 weeks prior to screening visit.
- •3. Patients in whom standard imaging work-up of MBC was recently (= 28 days) performed. Standard imaging must include: CT chest/abdomen, 18F-FDG-PET and bone scintigraphy.
- •4. Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
- •5. Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- •6. Primary tumor blocks available for confirmatory central laboratory ER/HER2 testing in the UMCG. If available a snap frozen sample of the primary tumor will also be centralized in the UMCG.
- •7. WHO performance status 0-2.
- •8. Patient is able to undergo PET imaging procedures.
- •9. Age >18 years of age, willing and able to comply with the protocol as judged by the investigator.
- •10. Signed written informed consent.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Contraindications for systemic treatment (as will be assigned based on biopsy and experimental scan results), either chemotherapy, hormonal therapy or anti-HER2 therapy, based on clinical judgment of treating medical oncologist and patient history.
- •2. Pregnant or lactating women.
- •3. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- •4. Inability to comply with study procedures.
- •5. Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.
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