NCT01974856已完成不适用
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies, Inc. Breast Cancer Intrinsic Subtype Test
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result.
研究概览
简要总结
The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.
详细描述
Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)
- •Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive.
- •HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
- •Postmenopausal women defined as:
- •Natural Amenorrhea > 12 months, regardless of age
- •Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
- •Radiological castration with amenorrhea > 3 months, regardless of age
- •Hysterectomy and postmenopausal blood levels
- •Able to give consent
- •Eligible for treatment of breast cancer with adjuvant chemotherapy
- •ECOG performance status of 0 or 1
排除标准
- •Tumor size T3-T4
- •Non-invasive breast cancer (e.g., Paget's disease, DCIS)
- •Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+)
- •Tumors that are estrogen-receptor negative or HER2 positive
- •Have metastatic disease
- •Unable to give informed consent
- •Unable to complete patient reported outcome surveys
- •Have contraindications for adjuvant chemotherapy
- •Age, performance status, significant comorbidities
- •ECOG performance status > 1
结局指标
主要结局
The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result.
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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