NCT01805908终止1 期
Imaging With 111In-Pertuzumab to Predict Response to Trastuzumab in HER2 Positive Metastatic or Locally Advanced Breast Cancer
Ontario Clinical Oncology Group (OCOG)2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8.
研究概览
简要总结
The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography (SPECT) imaging to predict who will respond to treatment with Trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastatic, locally recurrent (local recurrence not amenable to surgical resection of curative intent), or locally advanced (T3 or T4, any N, M0) adenocarcinoma of the breast.
- •Tumour HER2 positive by immunohistochemistry for HER2 protein over-expression or by Fluorescence in situ Hybridization (FISH) for HER2 gene amplification, as defined by American Society of Clinical Oncology/College of American Pathologists guidelines
- •Initiating treatment with TmAb
- •Clinically measurable disease (by RECIST for patients with metastatic disease).
排除标准
- •Male gender.
- •Less than 18 years of age.
- •Life expectancy < 12 weeks.
- •Only site of metastases is liver.
- •Eastern Cooperative Oncology Group (ECOG) performance status of >
- •Currently receiving PmAb or lapatinib for treatment of MBC.
- •Having received TmAb as adjuvant therapy within the previous 6 months.
- •Required to receive another radiopharmaceutical during the first week of the study.
- •Hypersensitivity to monoclonal antibodies.
- •Left Ventricular Ejection Fraction (LVEF) < 50% at baseline (within 42 days of study registration) as determined by either echocardiogram (ECHO) or Multi-Gated Acquisition (MUGA) scan.
- •Hematology and/or biochemistry parameters outside acceptable ranges:
- •absolute neutrophil count <1,500 cells/mm3,
- •platelet count <100,000 cells/mm3,
- •hemoglobin <9 g/dL,
- •total bilirubin > upper limit of normal (ULN) (unless subject has documented Gilbert's Syndrome),
- •aspartate aminotransferase (AST) [serum glutamic oxaloacetic transaminase(SGOT)] and alanine aminotransferase (ALT) [serum glutamic pyruvate transaminase(SGPT)] >2.5 × ULN,
- •serum creatinine >2.0 mg/dL or 177 μmol/L,
- •alanine aminotransferase (ALP) >2.5 x ULN.
- •Known pregnancy or lactating female (e.g. positive serum beta-human chorionic gonadotropin (B-hCG) pregnancy test).
- •For women of childbearing potential, failure to agree to use a highly effective form of contraception (patient and/or partner, e.g., surgical sterilization) or two effective forms of contraception (a reliable barrier method in conjunction with spermicidal jelly, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of study treatment.
- •Any condition, which in the investigator's opinion would not make the patient a suitable candidate for inclusion in the trial.
- •Participation in another clinical trial.
- •Inability to provide informed consent.
结局指标
主要结局
Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8.
时间窗: 8 days
The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 8 (Day 8 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.
Safety attributable to 111In-Pertuzumab injections
时间窗: 3 months
The safety, i.e. toxicities, attributable to 111In-Pertuzumab injections will be evaluated using the National Cancer Institute (NCI) Common Termination for Adverse Events Version 4.
次要结局
- Optimal mass dose of 111In-PmAb(3 months)
- Pharmacokinetics (PK) and tumour and normal tissue localization properties of 111In-PmAb will be measured.(3 months)
- Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.(3 months)
- Change in tumour SUV from Baseline to Day 36(3 months)
研究者
研究点 (2)
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