An observational study in Early Breast Cancer, Skin Condition and Quality of Life, sponsored by Pierre Fabre Medicament. Completed at 9 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Pierre Fabre Medicament · Observational
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.
Patients will complete the questionnaires at inclusion using a webbased PRO system
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 155 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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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.
Exclusion Criteria:
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.
Time frame: At inclusion
Quality of life data collected at the time of inclusion using the Skindex-16, Hairdex, and ItchyQoL questionnaires.
The Skindex-16 includes items distributed across three domains symptoms (items 1 to 4), emotions (items 5 to 11) and functioning (items 12 to 16) and are answered on a seven-point Likert scale (varying from 0-never bothered, to 6-always bothered), which represents the frequency with which the skin problem bothered the respondent during the past week. This is a 0-100 scale, higher the score, the more quality of life is impaired. The Hairdex is a valuable tool for evaluating disease-specific QoL in patients with hair disorders. It consists of 48 questions across five sections: symptoms, functioning, emotions, self-confidence, and stigmatization. Each question is self-graded on a scale of 0-4, with a score of 4 indicating the most severe change from a patient's baseline quality of life. The ItchyQoL is a questionnaire used to measure the QoL in patients with chronic pruritus. It is composed of 22 items regarding symptoms, functions, emotions and self-perception, and is currently under
Time frame: At inclusion
Ongoing dermatological toxicities reported by investigator according to Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0, November 2017)
1. Type of toxicity 2. Surface area involved (except for nails and oral dryness) 3. Start date 4. Clinical grading of the toxicity
Time frame: At inclusion
Demographics, and clinical characteristics at the time of inclusion, including the following items
1. Age, gender, weight, height 2. Menopausal status 3. Date of cancer diagnosis 4. Primary tumor location 5. T stage 6. Prior therapies for breast cancer (type, agent name, start date, stop date) 7. Endocrine therapy (agent name, start date) for breast cancer 8. Current dermatological care and sun-protective behaviors
Time frame: At inclusion
Exploratory outcomes: History of dermatological toxicities from the beginning of current treatment to the time of inclusion
1. Type of dermatological toxicity 2. Surface area (except for nails and oral dryness) 3. Start date and end date 4. Grade of the toxicity, if available 5. Change in hormonal treatment (adaptation, interruption), if applicable
Time frame: From beginning of current treatment to the time of inclusion
Subgroups of interest
* Age repartition by class (\< 35 years old, 35-50, 50-65, \> 65 years old) * Menopause status * Therapeutical choice before the 2/3 years of adjuvant endocrine therapy * Radiotherapy (yes / no) * Chemotherapy (yes / no), if yes, the information whether taxane was received or not will be collected * Adjuvant (yes/no) * Neoadjuvant (yes/no) * Target therapy (yes / no) * Type of adjuvant endocrine therapy Analyses of primary, secondary, and exploratory outcomes may be performed for some or all of these subgroups, subject to pertinence and the number of patients in each subgroup.
Time frame: At inclusion
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Pierre Fabre Medicament