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

Metastatic Breast Cancer Clinical Trial

— 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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06106711
• Other study ID #: CRO-2023-22
• Status: Not yet recruiting
• Start date: November 2, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Cristina Mazzega Fabbro, MSc
• Phone: 0434659111
• Email: cristina.mazzega[@]cro.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico (CRO)	Aviano	Pordenone
Italy	Fondazione IRCCS Istituto Nazionale dei tumori	Milano
Italy	Istituto Nazionale Tumori IRCCS G. Pascale	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Dose-reduction	to identify the percentage of patients who require a reduction in dosage due to suboptimal treatment tolerance	up to 1 year
Secondary	Treatment discontinuation	Identify the percentage of patients who discontinues cancer therapy due to suboptimal treatment tolerance	up to 1 year
Secondary	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
Secondary	To describe the actions taken to manage treatment-related AEs	Description of the actions taken to manage treatment-related AEs	up to 1 year
Secondary	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
Secondary	Sources of distress	Frequency for answers to Distress thermometer problem list	up to 1 year