Clinical trial 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early Breast Cancer
Skin Condition
Quality of Life
Keywords: Early breast cancer
Adjuvant endocrine therapy
Quality of life
Patient Reported Outcomes
skin toxicities
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2024-11-15
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

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)

Primary outcomes:
measure: Description of the quality-of-life data collected at the time of inclusion using the validated DLQI questionnaire
timeFrame: At inclusion
Secondary outcomes:
measure: Quality of life data collected at the time of inclusion using the Skindex-16, Hairdex, and ItchyQoL questionnaires.
timeFrame: At inclusion
measure: Ongoing dermatological toxicities reported by investigator according to Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0, November 2017)
timeFrame: At inclusion
measure: Demographics, and clinical characteristics at the time of inclusion, including the following items
timeFrame: At inclusion
Other outcomes:
measure: Exploratory outcomes: History of dermatological toxicities from the beginning of current treatment to the time of inclusion
timeFrame: From beginning of current treatment to the time of inclusion
measure: Subgroups of interest
timeFrame: At inclusion
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
city: Athenes
country: Greece
facility: Syrgos Hospital
city: Bologne
country: Italy
facility: Sant'Orsola-Malpighi Hospital - University of Bologna
city: Barcelone
country: Spain
facility: Hospital Del Mar
Study officials:
name: Vincent SIBAUD
role: PRINCIPAL_INVESTIGATOR
References: