Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology

About this trial

Few data about the impact of emotional distress (ED) on treatment efficacy in patients with metastatic breast cancer (mBC) are available.

Aim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.

Eligibility criteria

Qualifiers

Age over 18 years

Confirmed histological diagnosis of breast cancer

No prior treatment for advanced/metastatic cancer

cohort A (HR-/HER2-, PD-L1+): pembrolizumab or atezolizumab + chemotherapy

Disqualifiers

Pre-existing severe psychiatric disorders or other conditions that could impair the ability to provide informed consent

Inability to complete questionnaires

Presence of another malignancy in the previous 3 years

Symptomatic brain metastases

Trial design

Treatments tested in this trial

  • ED and quality of life assessment

Treatment groups

1,000 Participants
are divided into 4 treatment groups

Locations

37
Ospedali Riuniti di Ancona Ancona Italy
CRO (Centro di Riferimento Oncologico) Aviano Italy
Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata Bagno a Ripoli Italy
IRCCS Istituto Tumori Giovanni Paolo II Bari Italy

Sponsors and collaborators

European Institute of Oncology

Lead sponsor