The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT06106711
- Lead Sponsor
- Centro di Riferimento Oncologico - Aviano
- Brief Summary
The study stems from the need to detect adverse events arising after the administration of Antibody-Drug Conjugates (ADCs) used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.
- Detailed Description
The study stems from the need to detect adverse events arising after the administration of ADCs used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.Through the findings of toxicities related to the ADCs, it will be possible to highlight which are the issues that most affect patients undergoing these cancer treatments. The analysis of the data collected will also make it possible to highlight any toxicities not yet considered or/and of new onset. In addition useful elements may emerge from responses to the quality of life questionnaire, to cope with the difficulties expressed by patients regarding daily life activities, social relations, work and family. Such contributions will be fundamental to the construction of integrated care pathways, the aim of which is to involve a specialized nurse as part of a multidisciplinary team.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 92
- Female gender;
- Age ≥ 18 years;
- Signature of consent to participate in the study and to the processing of personal data (Privacy);
- Diagnosis of stage IV breast cancer;
- Systemic treatment with T-DM1, T-DXD or SG as monotherapy;
- Absence of cognitive decline, expressed by a score greater than or equal to 4 on the Six Item Screener questionnaire;
- Good understanding of the Italian language;
- Willingness and ability to adhere to scheduled visits, treatment plan, laboratory tests and study procedures.
- All patients who do not meet the above criteria will be excluded from the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life of patients during treatment up to 1 year To assess the quality of life of patients treated with TDM-1, T-DXd, and SG through the administration of the EORTC QLQ-C30 questionnaire. Results will be reported as median and quartiles
Adverse events (AEs) arising during treatment and degree of toxicity up to 1 year description of degree of toxicity of AEs classified using the international classification system CTCAE (version 5.0)
- Secondary Outcome Measures
Name Time Method Treatment discontinuation up to 1 year Identify the percentage of patients who discontinues cancer therapy due to suboptimal treatment tolerance
Dose-reduction up to 1 year to identify the percentage of patients who require a reduction in dosage due to suboptimal treatment tolerance
AEs - level of distress up to 1 year difference in distress levels measured with Distress thermometer between patients with different AEs secondary to cancer treatments
To describe the actions taken to manage treatment-related AEs up to 1 year Description of the actions taken to manage treatment-related AEs
Analyze the level of concordance between the AEs detected by health care personnel and the patient's subjective assessment up to 1 year Concordance between the AEs detected by health care personnel and the patient's subjective assessment
Sources of distress up to 1 year Frequency for answers to Distress thermometer problem list
Trial Locations
- Locations (3)
Centro di Riferimento Oncologico (CRO)
🇮🇹Aviano, Pordenone, Italy
Fondazione IRCCS Istituto Nazionale dei tumori
🇮🇹Milano, Italy
Istituto Nazionale Tumori IRCCS G. Pascale
🇮🇹Napoli, Italy