Early Breast CancerBCARENCT06690489
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)
An observational study of Early Breast Cancer and Skin Condition, run by Pierre Fabre Medicament at 9 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Breast Cancer, Skin Condition, Quality of Life
- How many people
- 155 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 22 Nov 2024to 26 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Females aged ≥ 18 years at inclusion.
- Histologically confirmed diagnosis of EBC, according to the WHO criteria and the TNM classification, at any time before inclusion.
- Still being treated with adjuvant endocrine monotherapy, initiated 2 years (up to 1 year and 9 months) to 3 years (up to 3 years and 6 months) before the inclusion in the study.
- Signed Informed Consent Form (ICF) or non-opposition, according to local regulations.
Who cannot join
- 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)
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Italy3 sites
Sant'Orsola-Malpighi Hospital University of Bologna
Bologna
Clinica Dermatologica dell'Università di Napoli "Federico II"
Naples
Fondazione Policlinico A. Gemelli
Roma
France2 sites
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31100
Greece2 sites
Sygros Hospital
Athens
Aristotle University of Thessaloniki
Thessaloniki
Spain2 sites
Hospital Del Mar
Barcelona
Hospital General de Fuerteventura
Las Palmas
About this study
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)
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.
Read the detailed description
Patients will complete the questionnaires at inclusion using a webbased PRO system
- Conditions
- Early Breast Cancer, Skin Condition, Quality of Life
- Keywords
- Early breast cancer, Adjuvant endocrine therapy, Quality of life, Patient Reported Outcomes, skin toxicities
- Medical subject headings
- Breast Neoplasms, Skin Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
Secondary outcomes (3)
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
Measured: At inclusion
Ongoing dermatological toxicities reported by investigator according to Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0, November 2017)
- Type of toxicity
- Surface area involved (except for nails and oral dryness)
- Start date
- Clinical grading of the toxicity
Measured: At inclusion
Demographics, and clinical characteristics at the time of inclusion, including the following items
- Age, gender, weight, height
- Menopausal status
- Date of cancer diagnosis
- Primary tumor location
- T stage
- Prior therapies for breast cancer (type, agent name, start date, stop date)
- Endocrine therapy (agent name, start date) for breast cancer
- Current dermatological care and sun-protective behaviors
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start22 Nov 2024
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent SIBAUD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690489
- Sponsor's protocol ID
- NIS18999
- Acronym
- BCARE
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06690489
- Acronym / sponsor ID
- BCARE / NIS18999
- Conditions
- Early Breast Cancer, Skin Condition, Quality of Life
- Keywords
- Early breast cancer, Adjuvant endocrine therapy, Quality of life, Patient Reported Outcomes, skin toxicities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Females aged ≥ 18 years at inclusion.
- Histologically confirmed diagnosis of EBC, according to the WHO criteria and the TNM classification, at any time before inclusion.
- Still being treated with adjuvant endocrine monotherapy, initiated 2 years (up to 1 year and 9 months) to 3 years (up to 3 years and 6 months) before the inclusion in the study.
- Signed Informed Consent Form (ICF) or non-opposition, according to local regulations.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the quality-of-life data collected at the time of inclusion using the validated DLQI questionnaire
Time frame: At inclusion
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.
3 secondary outcomes
Quality of life data collected at the time of inclusion using the Skindex-16, Hairdex, and ItchyQoL questionnaires.
Time frame: At inclusion
Ongoing dermatological toxicities reported by investigator according to Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0, November 2017)
Time frame: At inclusion
Demographics, and clinical characteristics at the time of inclusion, including the following items
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent SIBAUD principal investigator
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Breast Cancer and Skin Condition, run by Pierre Fabre Medicament at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, France, Greece, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the quality-of-life data collected at the time of inclusion using the validated DLQI questionnaire (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.