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Skin troubles from breast cancer treatment: a hidden burden on daily life

NCT ID NCT06690489

Knowledge-focused Sponsor: Pierre Fabre Medicament Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study involved 155 women with early breast cancer who had been taking hormone therapy for 2-3 years. Researchers wanted to understand how skin-related side effects from the treatment impact their quality of life. Participants filled out questionnaires about their skin symptoms and how they affected their daily activities and emotions. The goal was to measure the real-world burden of these skin issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

155 people

The number who actually took part.

Started

Nov 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 years (up to 1 year and 9 months) to 3 years (up to 3 years and 6 months) 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)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm skin disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early breast cancer Quality of life Skin condition

Contacts and locations

Locations

  • Aristotle University of Thessaloniki

    Thessaloniki, Greece

  • Clinica Dermatologica dell'Università di Napoli "Federico II"

    Naples, Italy

  • Fondazione Policlinico A. Gemelli

    Roma, Italy

  • Hospital Del Mar

    Barcelona, Spain

  • Hospital General de Fuerteventura

    Las Palmas, Spain

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse, 31100, France

  • Institut du Cancer de Montpellier - Val d'Aurelle

    Montpellier, France

  • Sant'Orsola-Malpighi Hospital University of Bologna

    Bologna, Italy

  • Sygros Hospital

    Athens, Greece

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