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)

Launched by PIERRE FABRE MEDICAMENT · Nov 13, 2024

Keywords

ClinConnect Summary

This clinical trial, called BCARE, is studying how skin-related side effects from treatment affect the quality of life of women with early breast cancer. The researchers want to understand the experiences of women who have been receiving a specific type of hormone therapy called adjuvant endocrine therapy for 2 to 3 years. Participants will fill out questionnaires that focus on skin issues, like itching or hair loss, to help the team gather information about how these side effects impact their daily lives.

To join the study, women must be at least 18 years old and have a confirmed diagnosis of early breast cancer. They should still be on the hormone therapy that started 2 to 3 years ago. However, women with certain pre-existing skin conditions or those receiving other specific cancer treatments are not eligible. If you choose to participate, you can expect to share your experiences regarding skin problems and how they affect your well-being. This study aims to improve understanding of the challenges faced by patients and may help guide better care in the future.

Gender

FEMALE

Eligibility criteria

• 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)