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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Breast Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 92

Contacts and Locations

• Study Contact: Name: Cristina Mazzega Fabbro, MSc; Phone Number: 0434659111; Email: cristina.mazzega@cro.it

Study Locations

• Italy
  • Milano, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
    • Contact: Giulia Antonacci; Email: giulia.antonacci@istitutotumori.mi.it
    • Principal Investigator: Giulia Antonacci
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori IRCCS G. Pascale
    • Contact: Maria Rosaria Esposito; Email: mariarosaria.esposito@istitutotumori.na.it
    • Principal Investigator: Maria Rosaria Esposito
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro di Riferimento Oncologico (CRO)
      • Contact: Cristina Mazzega Fabbro; Email: cristina.mazzega@cro.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano
• Investigators: Principal Investigator: Cristina Mazzega Fabbro, MSc, Centro di Riferimento Oncologico (CRO), IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): November 2, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CRO-2023-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No