NCT02395575已完成不适用
Prospective Study Evaluating the Clinical Impact of the Breast Cancer Intrinsic Subtype-Prosigna Test (Assay) in the Management of Early-stage Breast Cancers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test results.
研究概览
简要总结
The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.
详细描述
The secondary objectives will consist of:
- The evaluation of the confidence in the therapeutic indications of the practitioners before and after the test (assay) results, and by subgroups of cancers
- The evaluation of the rate of secondary effects of chemotherapy,
- The evaluation of the emotional state of patients faced with the therapeutic decision, of their degree of anxiety and of their functional status before and after the Prosigna test (assay) results
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 results.
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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