A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer (ONCOTYPEDX)
2014年3月26日 更新者：Ontario Clinical Oncology Group (OCOG)
A prospective population-based cohort study is being conducted in Ontario to evaluate whether the performance of Oncotype DX® changes the treatment recommended and the treatment received in women or men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy.
One thousand eligible consenting women and men will have their tumor tissue specimen sent to Genomic Health where the Oncotype DX® assay will be performed.
研究概览
详细说明
The evidence supporting the adoption of Oncotype DX® is relatively weak by the criteria used by the Ontario Health Technology Advisory Committee (OHTAC).
There is only one small published prospective study that reports on Oncotype DX® changing clinical management.
The economic models that estimated the potential advantages of using an Oncotype DX® guided treatment strategy may have overestimated the benefits because they assumed that all patients with tumors >1cm in the absence of Oncotype DX® testing would receive chemotherapy in addition to tamoxifen, and that the magnitude of benefit with chemotherapy over tamoxifen is relatively large, i.e. reduces recurrence risk by 74% and associated with an absolute benefit of 28%.
(The benefit comes from one trial and is applied to all patients).
It is estimated that there are about 3,300 incident cases with node negative, ER positive, HER2 neu negative tumors annually in Ontario, it is important to evaluate the adoption of this test for decision making in Ontario.
研究类型
介入性
注册 (实际的)
1011
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Barrie、Ontario、加拿大、L4M 6M2
- Simcoe Muskoka Cancer Program - Royal Victoria Hospital
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Belleville、Ontario、加拿大、K8N 5A9
- Quinte Healthcare Corporation
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Brampton、Ontario、加拿大、L6R 3J7
- William Osler Health Centre
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Brantford、Ontario、加拿大、N3R 1G9
- Brantford General Hospital
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Burlington、Ontario、加拿大、L7S 1W7
- Joseph Brant Hospital
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Cambridge、Ontario、加拿大、N1R 3G2
- Cambridge Memorial Hospital
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Hamilton、Ontario、加拿大、L8V 1C3
- Juravinski Cancer Centre
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Kingston、Ontario、加拿大、K7L 5P9
- Cancer Centre of Southeastern Ontario at Kingston
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Kitchener、Ontario、加拿大、N2G 1G3
- Grand River Regional Cancer Centre
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London、Ontario、加拿大、N6A 4L6
- London Regional Cancer Centre
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Markham、Ontario、加拿大、L6B 1A1
- Markham Stouffville Hospital
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Mississauga、Ontario、加拿大、L5M 2N1
- The Credit Valley Hospital
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Newmarket、Ontario、加拿大、L3Y 2P9
- Stronach Regional Cancer Centre
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Oshawa、Ontario、加拿大、L1G 2B9
- R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
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Ottawa、Ontario、加拿大、K1H 8L6
- The Ottawa Hospital Regional Cancer Centre
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Owen Sound、Ontario、加拿大、N4K 6M9
- Grey Bruce Health Services
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Peterborough、Ontario、加拿大、K9J 7C6
- Peterborough Regional Health Centre
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Richmond Hill、Ontario、加拿大、L4C 4Z3
- Mackenzie Health
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Sarnia、Ontario、加拿大、N7T 6S3
- Bluewater Health
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Sault Ste. Marie、Ontario、加拿大、P6B 0A8
- Algoma District Cancer Program - Sault Area Hospital
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Scarborough、Ontario、加拿大、M1P 2T7
- The Scarborough Hospital
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Scarborough、Ontario、加拿大、M1E 5E9
- Rouge Valley Health System
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St. Catharines、Ontario、加拿大、L2R 7C6
- Niagara Health System
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Sudbury、Ontario、加拿大、P3E 5J1
- Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
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Thunder Bay、Ontario、加拿大、P7B 6V4
- Thunder Bay Regional Health Sciences Centre
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Toronto、Ontario、加拿大、M5B 1W8
- St. Michael's Hospital
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Toronto、Ontario、加拿大、M4C 3E7
- Toronto East General Hospital
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Toronto、Ontario、加拿大、M5G 2M9
- Princess Margaret Hospital
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Toronto、Ontario、加拿大、M5G 1X5
- Mount Sinai Hospital
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Toronto、Ontario、加拿大、M2K 1E1
- North York General Hospital
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Toronto、Ontario、加拿大、M4N 3M5
- Sunnybrook Health Sciences - Odette Cancer Centre
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Toronto、Ontario、加拿大、M6R 1B5
- St. Joseph's Healthcare
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Toronto、Ontario、加拿大、M9C 1A5
- Trillium Health Centre
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Toronto、Ontario、加拿大、M9N 1N8
- Humber River Regional Cancer Centre
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Windsor、Ontario、加拿大、N8W 2X3
- Windsor Regional Cancer Centre
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease).
- Surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months.
Axillary lymph nodes assessed for tumor by:
(i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both
- Axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer <2mm by H&E stain).
- Tumor is estrogen receptor (ER) positive.
- Receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor).
- Being considered for adjuvant chemotherapy.
Exclusion Criteria:
- Axillary lymph node positive for cancer.
- Patients with inoperable locally advanced breast cancer.
- Metastatic breast cancer, including local ipsilateral recurrence.
- HER2 neu positive.
- Physician/Patient unwilling to comply with study protocol.
- Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Early Stage Breast Cancer
Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
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Gene signature test containing 21 genes (16 cancer-related genes, e.g., invasion, proliferation, ER, Her 2 and five reference genes) and generates an individualized recurrence score.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in treatment recommendation
大体时间：One month
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The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
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One month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Association between Oncotype DX® RS with other estimated risk calculations
大体时间：One month
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The level of association between the Oncotype DX® RS with estimated recurrence risk calculated by Adjuvant!
Online, as well as with traditional factors including tumor size, grade, and HER2 neu.
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One month
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Change in patient decisional conflict
大体时间：One month
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The change in the level of patient decisional conflict measured by the Decisional Conflict Scale (DCS).
Additionally, the DCS has three subscales: uncertainty, effective decision making, and factors contributing to uncertainty.
The change in each of these subscales will also be measured.
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One month
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Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.
大体时间：6 months
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To determine the robustness of the economic model of sequential Adjuvant!
Online followed by Oncotype DX®.
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mark N. Levine, MD、Ontario Clinical Oncology Group (OCOG)
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2014年2月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2011年8月24日
首先提交符合 QC 标准的
2011年8月24日
首次发布 (估计)
2011年8月26日
研究记录更新
最后更新发布 (估计)
2014年3月27日
上次提交的符合 QC 标准的更新
2014年3月26日
最后验证
2014年3月1日
更多信息
与本研究相关的术语
其他研究编号
- OCOG-2011-ONCOTYPEDX
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.