Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors in Postmenopausal Patients With Early Breast Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
To see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase inhibitors in postmenopausal patients with early breast cancer in terms of:
i) Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall survival
详细描述
The relationship between obesity and breast cancer is a complex one. Obesity is a risk factor for the development of breast cancer in postmenopausal women and has been linked to an increased risk of recurrence and decreased survival as compared to patients with normal weight.
The hypothesis that led to this study is that the amount of total-body aromatization capacity indicated by body mass index (BMI). In postmenopausal women and in premenopausal women with ovarian suppression, the major source of serum estrogens is the fat tissue, in which precursors are metabolized to estrogens by the enzyme aromatase. Thus, an increase in BMI leads to an increase in total-body aromatization and, consequently, an increase in oestrogen serum levels, which impact on breast cancer. Taken together, this suggests that BMI may serve as a useful surrogate parameter for total-body aromatization and eventually may be a practicable tool to tailor aromatase inhibitors (AIs) therapy for individual patients.
The study will include 360, postmenopausal patients with early breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (ER) and/or progesterone receptor (PR). Patients will be randomly assigned to receive tamoxifen 20 mg once daily or AIs (letrozole 2.5mg/ anastrozole 1mg/exemestane 25mg) once daily for five years. Patients with a tumour stage IB, IC, or II irrespective of nodal stage (<10 positive nodes) will be included. Weight and height will be taken at baseline for calculation of BMI according to the WHO criteria. The frequency of adverse events will be used to assess safety throughout the study.
The primary end point will be disease-free survival (DFS). Secondary end points will be recurrence-free survival and overall survival (OS). The data will be analyzed for DFS and OS according to the BMI subgroups as well as two treatment arms (tamoxifen v AIs). The frequency of adverse events will be used to assess safety throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal patients with breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (ER) and/or progesterone receptor (PR).
- •patients with a tumour stage IB, IC, or II irrespective of nodal stage (< 10 positive nodes)
排除标准
- •premenopausal patients,
- •ER/PR negative
研究组 & 干预措施
Arm A- Letrozole
Aromatase inhibitor- letrozole 2.5mg once daily for 5 years
干预措施: Letrozole (Drug)
Arm B- Tamoxifen
Tamoxifen 20 mg once daily for 5 years
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Disease free survival
时间窗: From date of random assignment to the first event during 5 years
Event in the form of locoregional recurrence, distant metastasis, cancer in the contralateral breast, second primary cancer, or death from any cause.
次要结局
- recurrence-free survival .(From date of randomization until the date of first documented progression during 5 years)
- overall survival (OS)(From day of diagnosis till date of death from disease/ other cause over an average of 5 years)
研究者
Dr Budhi Singh Yadav
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh