Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
EIRENE
The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study
2 other identifiers
observational
1,000
1 country
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedStudy Start
First participant enrolled
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
June 17, 2026
June 1, 2026
3.9 years
May 20, 2025
June 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS), according to the presence of ED at T0, in cohort A
Time from T0 (Cycle 1 Day 1) to disease progression or death
2 years
Secondary Outcomes (5)
Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D
2 years
Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1)
2 years
Objective response rate (ORR), according to the presence of ED at T0 and T1
2 years
Quality of life evaluation
3 months
Fear of cancer progression evaluation
3 months
Study Arms (4)
Cohort A (HR-/HER2-, PD-L1+)
Triple-negative Programmed Cell Death Ligand 1 (PD-L1)+ mBC patients receiving chemotherapy with immune checkpoint inhibitors (ICIs)
Cohort B (HR-/HER2-, PD-L1-)
Triple-negative PD-L1- mBC patients receiving chemotherapy
Cohort C (HR+/HER2-)
HR+/HER2- mBC patients receiving Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor + endocrine therapy
Cohort D (HER2+)
HER2+ mBC patients receiving chemotherapy + trastuzumab and pertuzumab
Interventions
Patients will undergo ED and quality of life assessments through specific questionnaires completion
Eligibility Criteria
Patients with mBC eligible for standard 1st line treatment
You may qualify if:
- Age over 18 years
- Confirmed histological diagnosis of breast cancer
- No prior treatment for advanced/metastatic cancer
- Indication to receive first-line therapy as per standard clinical practice based on the disease subtype:
- cohort A (HR-/HER2-, PD-L1+): pembrolizumab or atezolizumab + chemotherapy
- cohort B (HR-/HER2-, PD-L1-): chemotherapy
- cohort C (HR+/HER2-): CDK4/6 inhibitor + endocrine therapy
- cohort D (HER2+): chemotherapy + trastuzumab and pertuzumab
- Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 and/or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria
- Able to provide full informed consent for the study
You may not qualify if:
- 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
- Ongoing treatment with antidepressant and/or anxiolytic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
ASST Papa Giovanni XXIII
Bergamo, Italy
ASST Spedali Civili
Brescia, Italy
Ospedale A. Perrino
Brindisi, Italy
ASST della Valle Olona
Busto Arsizio, Italy
Ospedale Valduce
Como, Italy
Ospedale Careggi
Florence, Italy
Ospedale Policlinico San Martino
Genova, Italy
AOU Gaetano Martino di Messina
Messina, Italy
European Institute of Oncology
Milan, 20141, Italy
ASST Fatebenefratelli Sacco
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Ospedale Niguarda
Milan, Italy
Ospedale San Giuseppe MultiMedica
Milan, Italy
Policlinico di Milano
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
Ospedale Maggiore di Novara
Novara, Italy
Policlinico Universitario Paolo Giaccone
Palermo, Italy
Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano
Prato, Italy
Ospedale Infermi
Rimini, Italy
Policlinico Universitario Campus Bio-Medico
Roma, Italy
Policlinico Umberto I
Rome, Italy
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Azienda Ospedaliero Universitaria di Sassari
Sassari, Italy
ASL CN2 - Ospedale Michele e Pietro Ferrero
Verduno, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Ospedale Sacro Cuore Don Calabria - Negrar
Verona, Italy
ASST Brianza
Vimercate, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriella Pravettoni, MD, PhD
European Istitute of Oncology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2025
First Posted
May 29, 2025
Study Start
June 25, 2025
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
June 17, 2026
Record last verified: 2026-06