Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Tumor response by RECIST v1.1 or pathological response according to Chevallier system
研究概览
简要总结
The purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-HER2 therapy with Trastuzumab.
详细描述
Biopsy and/or surgical samples from Her2-positive breast cancer patients treated with Trastuzumab alone or in combinations with other regimens of chemotherapy with known clinical outcomes will be collected and subjected to mRNA sequencing. Expression profiles will be analysed using original bioinformatic platform Oncobox. Based on comparison of molecular pathways activation strength and clinical response to Trastuzumab and chemotherapy, this study aims to identify molecular markers predicting efficacy of therapy with Trastuzumab and the possibility of further relapse.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult females
- •histologically confirmed HER2-positive breast cancer
- •available FFPE samples of breast cancer tissue
- •patients treated with Trastuzumab alone or in combination(s) with other regimens of chemotherapy with known outcome according to RECIST 1.1
- •stage II or more
- •patients who have signed an informed consent
排除标准
- •less than 70% of intact tumor cells in available FFPE samples
研究组 & 干预措施
Trastuzumab monotherapy
Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
干预措施: RNA sequencing (Other)
Trastuzumab monotherapy
Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
干预措施: Transcriptome analysis (Other)
Trastuzumab monotherapy
Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
干预措施: Trastuzumab (Drug)
Chemotherapy plus Trastuzumab
Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
干预措施: RNA sequencing (Other)
Chemotherapy plus Trastuzumab
Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
干预措施: Transcriptome analysis (Other)
Chemotherapy plus Trastuzumab
Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
干预措施: Trastuzumab (Drug)
Chemotherapy plus Trastuzumab
Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Tumor response by RECIST v1.1 or pathological response according to Chevallier system
时间窗: 1 year
Tumor response by RECIST v1.1 or pathological response according to Chevallier system
次要结局
未报告次要终点
研究者
Anton A. Buzdin
Chief Scientific Officer
OmicsWay Corp.