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

NCT06106711 | Unknown

• 1 other identifier: CRO-2023-22
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 3

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Dose-reduction

  up to 1 year

• Treatment discontinuation

  up to 1 year

• AEs - level of distress

  up to 1 year

• To describe 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

  up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• All patients who do not meet the above criteria will be excluded from the study.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (3)

Centro di Riferimento Oncologico (CRO)

Aviano, Pordenone, 33081, Italy

Location

Fondazione IRCCS Istituto Nazionale dei tumori

Milan, 20133, Italy

Location

Istituto Nazionale Tumori IRCCS G. Pascale

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cristina Mazzega Fabbro, MSc

  Centro di Riferimento Oncologico (CRO), IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Mazzega Fabbro, MSc

CONTACT

0434659111; cristina.mazzega@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 2, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-09

Locations

IT (3)