Evaluating the impact of skin issues on quality of life in early breast cancer patients receiving hormone therapy
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)
This study is trying to see how skin problems affect the daily lives of women with early breast cancer who are receiving hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Pierre Fabre Medicament Industry-sponsored |
| Drugs / interventions | trastuzumab, neratinib, chemotherapy |
| Locations | 4 sites (Toulouse and 3 other locations) |
| Trial ID | NCT06690489 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how dermatological toxicities affect the quality of life in adult women diagnosed with early breast cancer who are undergoing adjuvant endocrine therapy. Participants will complete four specific quality of life questionnaires focused on skin-related issues at the time of their inclusion. The study will also collect data on patients' demographics, clinical characteristics, and any skin care practices they have adopted since starting their treatment. The research is being conducted across multiple locations in Europe, including France, Italy, and Greece.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a confirmed diagnosis of early breast cancer who have been on adjuvant endocrine therapy for 2 to 3 years.
Not a fit: Patients with chronic dermatological conditions prior to starting endocrine therapy or those receiving concurrent targeted therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into managing skin toxicities, ultimately improving the quality of life for patients undergoing treatment for early breast cancer.
How similar studies have performed: While this study focuses on a specific aspect of quality of life related to dermatological issues, similar observational studies have shown success in evaluating patient-reported outcomes in cancer treatments.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Toulouse and 3 other locations
- Institut Universitaire du Cancer Toulouse - Oncopole — Toulouse, France (Recruiting)
- Syrgos Hospital — Athenes, Greece (Not_yet_recruiting)
- Sant'Orsola-Malpighi Hospital - University of Bologna — Bologne, Italy (Not_yet_recruiting)
- Hospital Del Mar — Barcelone, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Vincent SIBAUD
- Study coordinator: Aline STENNEVIN, Global Medical Advisor
- Email: aline.stennevin@pierre-fabre.com
- Phone: +33 5 62 25 55 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.