Breast Cancer Clinical Trial
Official title:
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors in Postmenopausal Patients With Early Breast Cancer
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
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.
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