- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758146
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors
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
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Chandigarh, India, 91 160012
- Recruiting
- Department of Radiotherapy, Post Graduate Institute of Medical Education & Research
-
Contact:
- Budhi S Yadav, MD
- Phone Number: 6390 91 0172-275
- Email: drbudhi@gmail.com
-
Principal Investigator:
- Dr Budhi S Yadav, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Letroz, Femara, Letronat
Other Names:
|
Active Comparator: Arm B- Tamoxifen
Tamoxifen 20 mg once daily for 5 years
|
20 mg once daily for 5 years
Other Names:
|
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
Investigators
- Principal Investigator: Dr Budhi S Yadav, MD, Post Graduate Institute of Medical Education & Research, Chandigarh, India
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Breast Neoplasms
- Obesity
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Letrozole
- Tamoxifen
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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