Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors in Postmenopausal Patients With Early Breast Cancer|
- Disease free survival [ Time Frame: From date of random assignment to the first event during 5 years ] [ Designated as safety issue: No ]Event in the form of locoregional recurrence, distant metastasis, cancer in the contralateral breast, second primary cancer, or death from any cause.
- recurrence-free survival . [ Time Frame: From date of randomization until the date of first documented progression during 5 years ] [ Designated as safety issue: No ]Disease specific mortality
- overall survival (OS) [ Time Frame: From day of diagnosis till date of death from disease/ other cause over an average of 5 years ] [ Designated as safety issue: No ]Till death due to disease/ other cause over an average of 5 years
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Arm A- Letrozole
Aromatase inhibitor- letrozole 2.5mg once daily for 5 years
Letroz, Femara, Letronat
Other Name: 2.5 mg once daily for 5 years
Active Comparator: Arm B- Tamoxifen
Tamoxifen 20 mg once daily for 5 years
20 mg once daily for 5 years
Other Name: Canditam, Nolvadex
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758146
|Contact: Budhi S Yadav, MDfirstname.lastname@example.org|
|Department of Radiotherapy, Post Graduate Institute of Medical Education & Research||Recruiting|
|Chandigarh, India, 91 160012|
|Contact: Budhi S Yadav, MD 91 0172-275 ext 6390 email@example.com|
|Principal Investigator: Dr Budhi S Yadav, MD|
|Principal Investigator:||Dr Budhi S Yadav, MD||Post Graduate Institute of Medical Education & Research, Chandigarh, India|