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)

NCT06690489 | Completed

• 1 other identifier: NIS18999
• Study Type: observational
• Target: 155
• Locations: 4 countries
• Sites: 9

Brief 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.

Conditions

Early Breast Cancer; Skin Condition; Quality of Life

Keywords

Early breast cancer; Adjuvant endocrine therapy; Quality of life; Patient Reported Outcomes; skin toxicities

Outcome Measures

Primary Outcomes (1)

• Description of the quality-of-life data collected at the time of inclusion using the validated DLQI questionnaire

  The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week, including symptoms, feelings, daily activities, leisure, work, school, personal relationships, and treatment. The primary endpoint is the rate of patients with a DLQI score ≥ 6. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired: * 0 - 1 corresponds to no effect at all on patient's life, * 2 - 5 corresponds to small effect on patient's life, * 6 - 10 corresponds to moderate effect on patient's life, * 11 - 20 corresponds to very large effect on patient's life, * 21 - 30 corresponds to extremely large effect on patient's life.

  At inclusion

Secondary Outcomes (3)

• Quality of life data collected at the time of inclusion using the Skindex-16, Hairdex, and ItchyQoL questionnaires.

  At inclusion

• Ongoing dermatological toxicities reported by investigator according to Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0, November 2017)

  At inclusion

• Demographics, and clinical characteristics at the time of inclusion, including the following items

  At inclusion

Other Outcomes (2)

• Exploratory outcomes: History of dermatological toxicities from the beginning of current treatment to the time of inclusion

  From beginning of current treatment to the time of inclusion

• Subgroups of interest

  At inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population is female patients suffering from EBC and treated with adjuvant endocrine monotherapy for 2 to 3 years, who spontaneously visit a hospital from the EADV European task force, in European countries (including France, Greece, Italy and Spain). They will be invited to participate in the study, during the inclusion period. The study population is the source population meeting eligibility criteria listed hereafter during the inclusion period.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (9)

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, France

Location

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31100, France

Location

Sygros Hospital

Athens, Greece

Location

Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

Sant'Orsola-Malpighi Hospital University of Bologna

Bologna, Italy

Location

Clinica Dermatologica dell'Università di Napoli "Federico II"

Naples, Italy

Location

Fondazione Policlinico A. Gemelli

Roma, Italy

Location

Hospital Del Mar

Barcelona, Spain

Location

Hospital General de Fuerteventura

Las Palmas, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Skin Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vincent SIBAUD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 22, 2024
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

IT (3); GR (2); ES (2); FR (2)