protocolSection identificationModule nctId: NCT06346457, orgStudyIdInfo id: IRTG_P08, briefTitle: Breast Cancer & Antiestrogenic Therapy & Brain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: International Research Training Group 2804, class: OTHER, collaborators name: German Research Foundation, collaborators name: University Hospital Tuebingen, collaborators name: Uppsala University, descriptionModule briefSummary: The study aims to investigate the effect of anti-estrogenic therapy in breast cancer patients on neural reward processing, psychosexual health, and quality of life, in reproductive vs. menopausal women. The investigators are directly comparing four groups 1) premenopausal women diagnosed with breast cancer receiving anti-estrogenic therapy, 2) postmenopausal women diagnosed with breast cancer with and without previous hormonal replacement therapy, receiving anti-estrogenic therapy, 3) premenopausal healthy women, and 4) postmenopausal healthy women. Furthermore, via assessment and integration of various data including subjective/self-report data via questionnaires and a standardized interview, physiological/endocrine (via blood sample), psychological and neural data (including anatomical scans, Diffusion tensor imaging (DTI), resting state, and a reward processing paradigm), this project will shed light on the connection between the brain, anti-estrogenic therapy, and psychosexual health., conditionsModule conditions: Breast Cancer Female, conditions: Healthy Female, conditions: Menopause, conditions: Anti-estrogenic Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Tamoxifen, interventions name: Letrozole, interventions name: Letrozole + GnRH, outcomesModule primaryOutcomes measure: Correlations between antiestrogen hormone therapy and brain function & structure, primaryOutcomes measure: Correlations between antiestrogen hormone therapy and reward processing in both behavioral and neural aspects, primaryOutcomes measure: Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls, primaryOutcomes measure: Reward Processing Disparities: Contrasting Breast Cancer Patients with Healthy Controls, primaryOutcomes measure: Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls, secondaryOutcomes measure: Correlation between antiestrogen hormone therapy and psychosexual health, secondaryOutcomes measure: Correlation between antiestrogen hormone therapy and quality of life, secondaryOutcomes measure: Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls, secondaryOutcomes measure: Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls, secondaryOutcomes measure: Correlation between antiestrogen hormone therapy and cognitive changes, secondaryOutcomes measure: Quality of Life Disparities: Contrasting Breast Cancer Patients with Healthy Controls, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Tuebingen; Department of Psychiatry & Psychotherapy Tuebingen, city: Tuebingen, state: BW, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False