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

Instituto Jalisciense de Cancerologia

Status: Unknown

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

Treatments: Drug: Exemestane; Diagnostic Test: Recurrence; Drug: Tamoxifen; Drug: Anastrozole; Diagnostic Test: Basal

Study type: Observational

Funder types: Other

Identifiers

NCT04389424

1/15

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 98 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
• Signed consent

Exclusion criteria

• Mental retardation

Trial design

300 participants in 5 patient groups

Anastrozole

Description:

Breast cancer women with anastrozole treatment

Treatment:

Drug: Anastrozole

Tamoxifen

Description:

Breast cancer women with tamoxifen treatment

Treatment:

Drug: Tamoxifen

Exemestane

Description:

Breast cancer women with exemestane treatment

Treatment:

Drug: Exemestane

Basal

Description:

Breast cancer women luminal type without any endocrine treatment (at initial diagnosis)

Treatment:

Diagnostic Test: Basal

Recurrence

Description:

Breast cancer women luminal type with recurrence of disease during endocrine therapy

Treatment:

Drug: Anastrozole

Drug: Tamoxifen

Diagnostic Test: Recurrence