Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
92 patients diagnosed with stage IV breast cancer treated at the Department of Medical Oncology and Cancer Prevention, IRCCS National Cancer Institute of Aviano and at the other involved clinical centers considered eligible for the study will be enrolled, after providing written informed consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Mazzega Fabbro, MSc | Contact | 0434659111 | cristina.mazzega@cro.it |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Mazzega Fabbro, MSc | Centro di Riferimento Oncologico (CRO), IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro di Riferimento Oncologico (CRO) | Aviano | Pordenone | 33081 | Italy |
Not provided
Not provided
Not provided
Not provided
| 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 |
| Fondazione IRCCS Istituto Nazionale dei tumori | Milan | 20133 | Italy |
|
| Istituto Nazionale Tumori IRCCS G. Pascale | Naples | 80131 | Italy |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided