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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Postgraduate Institute of Medical Education and Research
Sponsor:
Information provided by (Responsible Party):
Dr Budhi Singh Yadav, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01758146
First received: December 1, 2012
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Tamoxifen
Drug: Letrozole
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 360
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)
Arms Assigned Interventions
Experimental: Arm A- To be given Aromatase inhibitors such as letrozole
Aromatase inhibitor- letrozole 2.5mg once daily for 5 years
Drug: Letrozole
Other Name: 2.5 mg once daily for 5 years
Active Comparator: Arm B- To be given tamoxifen
Tamoxifen 20 mg once daily for 5 years
Drug: Tamoxifen
20 mg once daily for 5 years

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758146

Contacts
Contact: Budhi S Yadav, MD 919815981176 drbudhi@gmail.com

Locations
India
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    drbudhi@gmail.com   
Principal Investigator: Dr Budhi S Yadav, MD         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Dr Budhi S Yadav, MD Post Graduate Institute of Medical Education & Research, Chandigarh, India
  More Information

No publications provided

Responsible Party: Dr Budhi Singh Yadav, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01758146     History of Changes
Other Study ID Numbers: BMI
Study First Received: December 1, 2012
Last Updated: December 31, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
Breast cancer
obesity
aromatase inhibitors
postmenopausal

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Tamoxifen
Letrozole
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014