Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Tamoxifen
Letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, obesity, aromatase inhibitors, postmenopausal
Eligibility 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
Sites / Locations
- Department of Radiotherapy, Post Graduate Institute of Medical Education & ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A- Letrozole
Arm B- Tamoxifen
Arm Description
Aromatase inhibitor- letrozole 2.5mg once daily for 5 years
Tamoxifen 20 mg once daily for 5 years
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
recurrence-free survival .
Disease specific mortality
overall survival (OS)
Till death due to disease/ other cause over an average of 5 years
Full Information
NCT ID
NCT01758146
First Posted
December 1, 2012
Last Updated
March 2, 2020
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01758146
Brief Title
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors
Official Title
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors in Postmenopausal Patients With Early Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, obesity, aromatase inhibitors, postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
412 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A- Letrozole
Arm Type
Experimental
Arm Description
Aromatase inhibitor- letrozole 2.5mg once daily for 5 years
Arm Title
Arm B- Tamoxifen
Arm Type
Active Comparator
Arm Description
Tamoxifen 20 mg once daily for 5 years
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Other Intervention Name(s)
Canditam, Nolvadex
Intervention Description
20 mg once daily for 5 years
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
2.5 mg once daily for 5 years
Intervention Description
Letroz, Femara, Letronat
Primary Outcome Measure Information:
Title
Disease free survival
Description
Event in the form of locoregional recurrence, distant metastasis, cancer in the contralateral breast, second primary cancer, or death from any cause.
Time Frame
From date of random assignment to the first event during 5 years
Secondary Outcome Measure Information:
Title
recurrence-free survival .
Description
Disease specific mortality
Time Frame
From date of randomization until the date of first documented progression during 5 years
Title
overall survival (OS)
Description
Till death due to disease/ other cause over an average of 5 years
Time Frame
From day of diagnosis till date of death from disease/ other cause over an average of 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Budhi S Yadav, MD
Phone
919815981176
Email
drbudhi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Budhi S Yadav, MD
Organizational Affiliation
Post Graduate Institute of Medical Education & Research, Chandigarh, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiotherapy, Post Graduate Institute of Medical Education & Research
City
Chandigarh
ZIP/Postal Code
91 160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Budhi S Yadav, MD
Phone
91 0172-275
Ext
6390
Email
drbudhi@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr Budhi S Yadav, MD
12. IPD Sharing Statement
Learn more about this trial
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors
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