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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Page 1 of 1 (3 locations)

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