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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-22

Study Completion Date

2025-11-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients

NCT07151911

Breast Cancer

RECRUITING

Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

NCT01049425

Primary Breast Cancer Her2 Non-overexpressing

COMPLETED PHASE3

Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

NCT07021846

Breast Cancer

RECRUITING NA

Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

NCT01948726

Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost

COMPLETED NA

ME-344 in Early HER2-negative Breast Cancer With Antiangiogenic-induced Mitochondrial Metabolism

NCT02806817

Breast Cancer Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Early-Stage Breast Carcinoma

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Breast Cancer Skin Condition Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No