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)

Pierre Fabre

Status: Enrolling

Conditions: Quality of Life; Skin Condition; Early Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT06690489

NIS18999

Details and patient eligibility

About

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.

Full description

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

Enrollment: 156 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Females aged ≥ 18 years at inclusion.
2. Histologically confirmed diagnosis of EBC, according to the WHO criteria and the TNM classification, at any time before inclusion.
3. Still being treated with adjuvant endocrine monotherapy, initiated 2 to 3 years ago before the inclusion in the study.
4. Signed Informed Consent Form (ICF) or non-opposition, according to local regulations.

Exclusion criteria

1. Patients not able to read, understand and complete Questionnaires in local language.
2. with chronic dermatological conditions (treated or not) before initiating the adjuvant endocrine therapy that could interfere with the quality of life.
3. Patients with concomitant targeted therapies with adjuvant endocrine therapy such as CDK4/6 inhibitors or trastuzumab, and patients with ongoing treatment with neratinib.
4. Patients having relevant or severe comorbidities requiring complex therapeutic treatment.
5. Patients having a persistent post-chemotherapy alopecia (at least of grade 1)