Actively Recruiting
Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
Led by European Institute of Oncology · Updated on 2026-03-25
1000
Participants Needed
37
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Confirmed histological diagnosis of breast cancer
- No prior treatment for advanced/metastatic cancer
- Planned first-line therapy according to disease subtype, including:
- Cohort A (HR-/HER2-, PD-L1+): pembrolizumab or atezolizumab plus chemotherapy
- Cohort B (HR-/HER2-, PD-L1-): chemotherapy
- Cohort C (HR+/HER2-): CDK4/6 inhibitor plus endocrine therapy
- Cohort D (HER2+): chemotherapy plus trastuzumab and pertuzumab
- Presence of measurable disease by RECIST v.1.1 and/or PERCIST criteria
- Ability to provide full informed consent for the study
You will not qualify if you...
- Pre-existing severe psychiatric disorders or other conditions impairing informed consent
- Inability to complete questionnaires
- Presence of another malignancy within the previous 3 years
- Symptomatic brain metastases
- Current treatment with antidepressant and/or anxiolytic drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Ospedali Riuniti di Ancona
Ancona, Italy
Not Yet Recruiting
2
CRO (Centro di Riferimento Oncologico)
Aviano, Italy
Not Yet Recruiting
3
Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata
Bagno a Ripoli, Italy
Actively Recruiting
4
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
Not Yet Recruiting
5
ASST Papa Giovanni XXIII
Bergamo, Italy
Not Yet Recruiting
6
ASST Spedali Civili
Brescia, Italy
Not Yet Recruiting
7
Ospedale A. Perrino
Brindisi, Italy
Not Yet Recruiting
8
ASST della Valle Olona
Busto Arsizio, Italy
Not Yet Recruiting
9
Ospedale Valduce
Como, Italy
Not Yet Recruiting
10
Ospedale Careggi
Florence, Italy
Not Yet Recruiting
11
Ospedale Policlinico San Martino
Genova, Italy
Not Yet Recruiting
12
AOU Gaetano Martino di Messina
Messina, Italy
Actively Recruiting
13
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
14
ASST Fatebenefratelli Sacco
Milan, Italy
Not Yet Recruiting
15
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Not Yet Recruiting
16
IRCCS Ospedale San Raffaele
Milan, Italy
Not Yet Recruiting
17
Ospedale Niguarda
Milan, Italy
Not Yet Recruiting
18
Ospedale San Giuseppe MultiMedica
Milan, Italy
Not Yet Recruiting
19
Policlinico di Milano
Milan, Italy
Not Yet Recruiting
20
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy
Not Yet Recruiting
21
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Not Yet Recruiting
22
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
Not Yet Recruiting
23
Ospedale Maggiore di Novara
Novara, Italy
Not Yet Recruiting
24
Policlinico Universitario Paolo Giaccone
Palermo, Italy
Not Yet Recruiting
25
Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
26
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Not Yet Recruiting
27
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Actively Recruiting
28
Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano
Prato, Italy
Not Yet Recruiting
29
Ospedale Infermi
Rimini, Italy
Not Yet Recruiting
30
Policlinico Universitario Campus Bio-Medico
Roma, Italy
Not Yet Recruiting
31
Policlinico Umberto I
Rome, Italy
Not Yet Recruiting
32
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Actively Recruiting
33
Azienda Ospedaliero Universitaria di Sassari
Sassari, Italy
Actively Recruiting
34
ASL CN2 - Ospedale Michele e Pietro Ferrero
Verduno, Italy
Actively Recruiting
35
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Not Yet Recruiting
36
Ospedale Sacro Cuore Don Calabria - Negrar
Verona, Italy
Not Yet Recruiting
37
ASST Brianza
Vimercate, Italy
Not Yet Recruiting
Research Team
G
Gabriella Pravettoni, MD, PhD
CONTACT
M
Mara Negri
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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