Metastatic Breast Cancer
Conditions
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.
Interventions
None listed
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) arising during treatment and degree of toxicity | up to 1 year | Frequency adverse events (AEs) arising during treatment with TDM-1, T-DXd and SG |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Dose-reduction | up to 1 year | to identify the percentage of patients who require a reduction in dosage due to suboptimal treatment tolerance |
| Sources of distress | up to 1 year | Frequency for answers to Distress thermometer problem list |
| 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 |
| Treatment discontinuation | up to 1 year | Identify the percentage of patients who discontinues cancer therapy due to suboptimal treatment tolerance |
Countries
Italy
Contacts
Primary ContactCristina Mazzega Fabbro, MSc
Outcome results
None listed