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: Recruiting
Location: See all (9) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Females aged ≥ 18 years at inclusion.

• Histologically confirmed diagnosis of EBC, according to the WHO criteria and the TNM classification, at any time before inclusion.

• Still being treated with adjuvant endocrine monotherapy, initiated 2 to 3 years ago before the inclusion in the study.

• Signed Informed Consent Form (ICF) or non-opposition, according to local regulations.

Locations
Other Locations
France
Institut du Cancer de Montpellier - Val d'Aurelle
RECRUITING
Montpellier
Institut Universitaire du Cancer Toulouse - Oncopole
RECRUITING
Toulouse
Greece
Sygros Hospital
RECRUITING
Athens
Aristotle University of Thessaloniki
RECRUITING
Thessaloniki
Italy
Sant'Orsola-Malpighi Hospital University of Bologna
RECRUITING
Bologna
Clinica Dermatologica dell'Università di Napoli Federico II
RECRUITING
Napoli
Fondazione Policlinico A. Gemelli
RECRUITING
Roma
Spain
Hospital Del Mar
RECRUITING
Barcelona
Hospital General de Fuerteventura
RECRUITING
Las Palmas
Contact Information
Primary
Aline STENNEVIN, Global Medical Advisor
aline.stennevin@pierre-fabre.com
+33 5 62 25 55 66
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2026-03
Participants
Target number of participants: 156
Related Therapeutic Areas
Sponsors
Leads: Pierre Fabre Medicament

This content was sourced from clinicaltrials.gov