Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients Receiving Aromatase Inhibitor Therapy - A Pilot Study (AIMS)
In 2005, the EBCIG demonstrated the efficacy of tamoxifen in improving overall survival in hormone receptor positive breast cancers. However, tamoxifen shows partial estrogen agonist activity, which is responsible for the drug's detrimental effects such as endometrial carcinoma, thromboembolism, and tamoxifen resistance. More recently, aromatase inhibitors have been shown to be superior to tamoxifen in the metastatic and adjuvant settings. The ATAC trial demonstrated improved disease-free survival (DFS) for 5 years of anastrozole compared to 5 years of tamoxifen 3. The BIG 1-98 trial results demonstrated that after a median follow-up of 25.8 months, letrozole improved DFS and distant DFS when compared to tamoxifen. Based on these results, adjuvant hormonal therapy with Aromatase Inhibitors (AI) has become the preferred therapy for post-menopausal woman.
However, AI therapy is also associated with toxicities that merit in-depth studies, one of them being an increase in musculoskeletal pain. In the ATAC trial, at a median follow-up of 5.7 years, arthralgia was significantly higher (35.6% vs. 29.4%) and fractures were also increased (11.0% vs. 7.7%) when anastrozole was administered for 5 years following surgery with or without chemotherapy 3. The incidence of arthralgia was also significantly higher in the MA-17 trial, with 25% of patients receiving letrozole developing arthralgia compared with 21% in the placebo group following 5 to 6 years of tamoxifen 5.
Traditionally in cancer clinical trials, the reporting of musculoskeletal pain has been based on the "Common Terminology Criteria for Adverse Events", which covers a wide range of symptoms and does not facilitate the documentation of a pain syndrome in a specific manner. Therefore, there is a need to design a study that will describe the nature of the pain associated with the administration of AI therapy using tools that have been validated for capturing a multidimensional phenomenon such as pain.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Quebec
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Montréal、Quebec、加拿大、H2W 1T8
- Centre Hospitalier de l'Université de Montréal
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Female
- Invasive carcinoma of the breast confirmed by needle biopsy or final pathological evaluation of the surgical specimen
- Breast cancer Stage I, II or IIIa
- ER and/or PR+
- No evidence of metastatic disease
- Post-menopausal
- May or may not have received adjuvant or neoadjuvant chemotherapy
- Bilateral infiltrating carcinoma are eligible
Exclusion Criteria:
- Men not eligible
- Other malignancies
- Patients who have received neoadjuvant or adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor
- Ongoing treatment with any sex hormonal therapy (these patients are eligible if this therapy is discontinued prior to entry)
- Therapy with hormonal agent such as raloxifene for osteoporosis
- Patients receiving glucocorticoids
- Psychiatric or addictive disorders
- Inability to read English or French
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Musculoskeletal pain
大体时间:Every two weeks
|
Every two weeks
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次要结果测量
结果测量 |
大体时间 |
---|---|
Lymphocyte gene expression profiling
大体时间:Every two weeks
|
Every two weeks
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合作者和调查者
合作者
调查人员
- 首席研究员:André Robidoux, MD、Centre hospitalier de l'Université de Montréal (CHUM)
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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