Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer

Study Overview
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Brief Summary
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The protocol involves measurement of 25 hidroxy vitamin D, gene expression of cytochrome and vitamin D receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism.

Official Title
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Evaluation of the Relationship Between Drug Therapy, Food Consumption, Body Composition and Plasma Micronutients Levels With the Expression of Genes Related to Metabolism, Aging and Immunity in Women With Breast Cancer.

Conditions
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Breast Cancer, Endocrine Therapy, Endocrine Therapy Adverse Reaction, Vitamin D Deficiency, Nutrition Disorders, Obesity

Intervention / Treatment
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* Drug: Tamoxifen
* Drug: Exemestane
* Drug: Anastrozole
* Diagnostic Test: Basal
* Diagnostic Test: Recurrence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy Signed consent Exclusion Criteria: Mental retardation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 98 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anastrozole<br>Breast cancer women with anastrozole treatment | Drug: Anastrozole<br>* Use of anastrozole for breast cancer recurrence prevention<br>|
| Tamoxifen<br>Breast cancer women with tamoxifen treatment | Drug: Tamoxifen<br>* Use of tamoxifen for breast cancer recurrence prevention<br>|
| Exemestane<br>Breast cancer women with exemestane treatment | Drug: Exemestane<br>* Use of exemestane for breast cancer recurrence prevention<br>|
| Basal<br>Breast cancer women luminal type without any endocrine treatment (at initial diagnosis) | Diagnostic Test: Basal<br>* Initial diagnosis of breast cacner by biopsy or mastectomy<br>* Other names: Breast cancer initial diagnosis;|
| Recurrence<br>Breast cancer women luminal type with recurrence of disease during endocrine therapy | Drug: Tamoxifen<br>* Use of tamoxifen for breast cancer recurrence prevention<br>Drug: Anastrozole<br>* Use of anastrozole for breast cancer recurrence prevention<br>Diagnostic Test: Recurrence<br>* Breast cancer recurrence under endocrine therapy<br>* Other names: Breast cancer recurrence under endoctine therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hidroxy Vitamin D Concentration | Plasma levels of Hidroxy Vitamin D | One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy) | 
| Body Composition | Body composition (bioimpedance) | One time at enroll with at least 3 months of endocrine therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tamoxifen plasma levels | Tamoxifen plasma levels | One time. After minimum 3 months of tamoxifen treatment | 
| Anastrozole | Anastrozole plasma levels | One time. After minimum 3 months of anastrozole treatment | 
| Exemestane | Exemestane plasma levels | One time. After minimum 3 months of exemestane treatment | 
| Recurrence | Recurrence of breast cancer after endocrine therapy with tamoxifen or aromatase inhibitors | One time. In recurrence after at least 3 months with endocrine therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tamoxifen, Vitamin D, Adverse, Cytochrome p450, VDR, Nutrients, Gene Expression, Anastrozole, Exemestane