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Trial Title:
The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
NCT ID:
NCT06106711
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO)
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Contact:
Last name:
Cristina Mazzega Fabbro
Email:
cristina.mazzega@cro.it
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Contact:
Last name:
Giulia Antonacci
Email:
giulia.antonacci@istitutotumori.mi.it
Investigator:
Last name:
Giulia Antonacci
Email:
Principal Investigator
Facility:
Name:
Istituto Nazionale Tumori IRCCS G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Contact:
Last name:
Maria Rosaria Esposito
Email:
mariarosaria.esposito@istitutotumori.na.it
Investigator:
Last name:
Maria Rosaria Esposito
Email:
Principal Investigator
Start date:
November 2, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106711
