Status:
UNKNOWN
The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
Lead Sponsor:
Centro di Riferimento Oncologico - Aviano
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- All patients who do not meet the above criteria will be excluded from the study.
Key Trial Info
Start Date :
November 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06106711
Start Date
November 2 2023
End Date
September 30 2024
Last Update
October 30 2023
Active Locations (3)
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1
Centro di Riferimento Oncologico (CRO)
Aviano, Pordenone, Italy, 33081
2
Fondazione IRCCS Istituto Nazionale dei tumori
Milan, Italy, 20133
3
Istituto Nazionale Tumori IRCCS G. Pascale
Napoli, Italy, 80131