Clinical trial · Observational
The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
NCT06106711CI-TRIAL-00070884EVAunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Adverse events (AEs) arising during treatment and degree of toxicity
- timeFrame
- up to 1 year
- description
- Frequency adverse events (AEs) arising during treatment with TDM-1, T-DXd and SG
- measure
- Adverse events (AEs) arising during treatment and degree of toxicity
- timeFrame
- up to 1 year
- description
- description of degree of toxicity of AEs classified using the international classification system CTCAE (version 5.0)
- measure
- Quality of life of patients during treatment
- timeFrame
- up to 1 year
- description
- 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
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.