The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).

Conditions
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Metastatic Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: All patients who do not meet the above criteria will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) arising during treatment and degree of toxicity | Frequency adverse events (AEs) arising during treatment with TDM-1, T-DXd and SG | up to 1 year | 
| Adverse events (AEs) arising during treatment and degree of toxicity | description of degree of toxicity of AEs classified using the international classification system CTCAE (version 5.0) | up to 1 year | 
| Quality of life of patients during treatment | 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 | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-reduction | to identify the percentage of patients who require a reduction in dosage due to suboptimal treatment tolerance | up to 1 year | 
| Treatment discontinuation | Identify the percentage of patients who discontinues cancer therapy due to suboptimal treatment tolerance | up to 1 year | 
| AEs - level of distress | difference in distress levels measured with Distress thermometer between patients with different AEs secondary to cancer treatments | up to 1 year | 
| To describe the actions taken to manage treatment-related AEs | Description of the actions taken to manage treatment-related AEs | up to 1 year | 
| Analyze the level of concordance between the AEs detected by health care personnel and the patient's subjective assessment | Concordance between the AEs detected by health care personnel and the patient's subjective assessment | up to 1 year | 
| Sources of distress | Frequency for answers to Distress thermometer problem list | up to 1 year |