NCT06690489

An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients With Early Breast Cancer Treated With Adjuvant Endocrine Therapy - BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological Adverse Events)

Impact of Dermatological Toxicities on Quality of Life in Patients With Early Breast Cancer Exposed to Adjuvant Endocrine Therapy: a Real-world Cross-sectional Study. BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological Adverse Events)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this European observational study (Frane, Spain, italy, Spain and Greece) is to describe the quality of life related to dermatological toxicities, in adult women patients with Early Breast Cancer (EBC), treated with an ongoing adjuvant endocrine monotherapy initiated for 2 to 3 years ago before inclusion in the study. In order to answer these objectives, the patient are completing 4 quality of life questionnaires focussed on dermatological issues (DLQI, Skindex-16, Hairdex and ItchyQoL) at the time of the inclusion. Early Breast Cancer (EBC) diagnosis and history, demographics/clinical characteristics, skin care/sun protection care and skin toxicities since start of the adjuvant endocrine therapy will be collected by the investigator in the eCRF.

Detailed description

Patients will complete the questionnaires at inclusion using a webbased PRO system

Conditions

• Early Breast Cancer
• Skin Condition
• Quality of Life

Timeline

• Start date: 2024-11-22
• Primary completion: 2025-11-26
• Completion: 2025-11-26
• First posted: 2024-11-15
• Last updated: 2026-01-12

Locations

9 sites across 4 countries: France, Greece, Italy, Spain