Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01758146
• Other study ID #: BMI
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: June 2020

Study information

• Verified date: March 2020
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Budhi S Yadav, MD
• Phone: 919815981176
• Email: drbudhi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 412
• Est. completion date: June 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• premenopausal patients,

• ER/PR negative

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity

Intervention

Drug:
• Tamoxifen
20 mg once daily for 5 years
• Letrozole
Letroz, Femara, Letronat

Locations

Country	Name	City	State
India	Department of Radiotherapy, Post Graduate Institute of Medical Education & Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	Event in the form of locoregional recurrence, distant metastasis, cancer in the contralateral breast, second primary cancer, or death from any cause.	From date of random assignment to the first event during 5 years
Secondary	recurrence-free survival .	Disease specific mortality	From date of randomization until the date of first documented progression during 5 years
Secondary	overall survival (OS)	Till death due to disease/ other cause over an average of 5 years	From day of diagnosis till date of death from disease/ other cause over an average of 5 years