Clinical trial NCT06106711: The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
Official title: The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Breast Cancer
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events (AEs) arising during treatment and degree of toxicity
timeFrame: up to 1 year
measure: Adverse events (AEs) arising during treatment and degree of toxicity
timeFrame: up to 1 year
measure: Quality of life of patients during treatment
timeFrame: up to 1 year
Secondary outcomes:
measure: Dose-reduction
timeFrame: up to 1 year
measure: Treatment discontinuation
timeFrame: up to 1 year
measure: AEs - level of distress
timeFrame: up to 1 year
measure: To describe the actions taken to manage treatment-related AEs
timeFrame: up to 1 year
measure: Analyze the level of concordance between the AEs detected by health care personnel and the patient's subjective assessment
timeFrame: up to 1 year
measure: Sources of distress
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO)
state: Pordenone
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei tumori
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS G. Pascale
Study officials:
affiliation: Centro di Riferimento Oncologico (CRO), IRCCS
name: Cristina Mazzega Fabbro, MSc
role: PRINCIPAL_INVESTIGATOR
References: