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

March 2, 2020 updated by: Dr Budhi Singh Yadav, Postgraduate Institute of Medical Education and Research

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

412

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 91 160012
        • Recruiting
        • Department of Radiotherapy, Post Graduate Institute of Medical Education & Research
        • Contact:
        • Principal Investigator:
          • Dr Budhi S Yadav, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A- Letrozole
Aromatase inhibitor- letrozole 2.5mg once daily for 5 years
Drug: Letrozole
Letroz, Femara, Letronat
Other Names:
  • 2.5 mg once daily for 5 years
Active Comparator: Arm B- Tamoxifen
Tamoxifen 20 mg once daily for 5 years
Drug: Tamoxifen
20 mg once daily for 5 years
Other Names:
  • Canditam, Nolvadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 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.
From date of random assignment to the first event during 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence-free survival .
Time Frame: From date of randomization until the date of first documented progression during 5 years
Disease specific mortality
From date of randomization until the date of first documented progression during 5 years
overall survival (OS)
Time Frame: From day of diagnosis till date of death from disease/ other cause over an average of 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Dr Budhi S Yadav, MD, Post Graduate Institute of Medical Education & Research, Chandigarh, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

December 1, 2012

First Submitted That Met QC Criteria

December 31, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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