Metastatic Breast CancerEIRENENCT06994377
Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
An observational study of Metastatic Breast Cancer, run by European Institute of Oncology at 37 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- ED and quality of life assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 37 sitesItaly
- Study dates
- 25 Jun 2025to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mBC eligible for standard 1st line treatment
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
Italy37 sites, 37 recruiting
- Not yet recruiting
Ospedali Riuniti di Ancona
Ancona
Rossana Berardi
- Not yet recruiting
CRO (Centro di Riferimento Oncologico)
Aviano
Fabio Puglisi, MD
- Recruiting
Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata
Bagno a Ripoli
Carlotta Bacci, MD
- Not yet recruiting
IRCCS Istituto Tumori Giovanni Paolo II
Bari
Nicola Silvestris, MD
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo
Alberto Zambelli, MD
- Not yet recruiting
ASST Spedali Civili
Brescia
Rebecca Pedersini, MD
- Not yet recruiting
Ospedale A. Perrino
Brindisi
Saverio Cinieri, MD
- Not yet recruiting
ASST della Valle Olona
Busto Arsizio
Maria Marconi, MD
- Not yet recruiting
Ospedale Valduce
Como
Giovanni Scognamiglio, MD
- Not yet recruiting
Ospedale Careggi
Florence
Icro Meattini, MD
- Not yet recruiting
Ospedale Policlinico San Martino
Genova
Lucia Del Mastro, MD
- Recruiting
AOU Gaetano Martino di Messina
Messina
Massimilano Berretta, MD
- Recruiting
European Institute of Oncology
Milan, 20141
Gabriella Pravettoni, MD
- Not yet recruiting
ASST Fatebenefratelli Sacco
Milan
Nicla La Verde, MD
- Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Claudio Vernieri, MD
- Not yet recruiting
IRCCS Ospedale San Raffaele
Milan
Giulia Viale, MD
- Not yet recruiting
Ospedale Niguarda
Milan
Salvatore Siena, MD
- Not yet recruiting
Ospedale San Giuseppe MultiMedica
Milan
Pier Francesco Ferrucci, MD
- Not yet recruiting
Policlinico di Milano
Milan
Ornella Garrone, MD
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena
Angela Toss, MD
- Not yet recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
Roberto Bianco, MD
- Not yet recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples
Michelino De Laurentiis, MD
- Not yet recruiting
Ospedale Maggiore di Novara
Novara
Alessandra Gennari, MD
- Not yet recruiting
Policlinico Universitario Paolo Giaccone
Palermo
Antonio Russo, MD
- Not yet recruiting
Policlinico San Matteo
Pavia
Paolo Pedrazzoli, MD
- Not yet recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa
Chiara Cremolini, MD
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa
Carmelo Bengala, MD
- Recruiting
Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano
Prato
Laura Biganzoli, MD
- Not yet recruiting
Ospedale Infermi
Rimini
Lorenzo Gianni, MD
- Not yet recruiting
Policlinico Universitario Campus Bio-Medico
Roma
Francesco Pantano, MD
- Not yet recruiting
Policlinico Umberto I
Rome
Andrea Botticelli, MD
- Recruiting
Policlinico Universitario Agostino Gemelli IRCCS
Rome
Alessandra Fabi, MD
- Recruiting
Azienda Ospedaliero Universitaria di Sassari
Sassari
Valeria Sanna, MD
- Recruiting
ASL CN2 - Ospedale Michele e Pietro Ferrero
Verduno
Veronica Prati, MD
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Elena Fiorio, MD
- Not yet recruiting
Ospedale Sacro Cuore Don Calabria - Negrar
Verona
Stefania Gori, MD
- Not yet recruiting
ASST Brianza
Vimercate
Paola Tagliabue, MD
About this study
Official title: The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study
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.
Read the detailed description
Metastatic breast cancer (mBC) is the most incident and prevalent cancer in the world and, according to a recent meta-analysis, 50% of patients with BC report emotional distress (ED).
In patients with cancer, ED negatively impacts treatment adherence, ability to self-manage the physical and emotional consequences of cancer symptoms and treatment-related adverse events, and overall quality of life. ED has been shown to directly affect treatment outcomes in patients with breast cancer, with studies demonstrating that psychological well-being plays a critical role in therapeutic success.
Furthermore, recent studies showed that baseline ED is associated with a lower efficacy of immunotherapy in patients with non-small cell lung cancer (NSCLC) or melanoma.
Few data about the impact of ED on treatment efficacy in patients with mBC are available. In the first line setting patients receive endocrine therapy, chemotherapy, immunotherapy and/or targeted therapy according to the disease subtype. These agents display different mechanisms of action, which involve the immune system at different levels. However, the role of ED on the efficacy of these treatments according to the BC subtype is unknown.
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
- Metastatic Breast Cancer
- Being tested
- ED and quality of life assessment
- Keywords
- Metastatic Breast Cancer, Emotional Distress, First Line Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED and quality of life assessmentBehavioural
Patients will undergo ED and quality of life assessments through specific questionnaires completion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (HR-/HER2-, PD-L1+) | Triple-negative Programmed Cell Death Ligand 1 (PD-L1)+ mBC patients receiving chemotherapy with immune checkpoint inhibitors (ICIs) Receives: Behavioral: ED and quality of life assessment | |
| Cohort B (HR-/HER2-, PD-L1-) | Triple-negative PD-L1- mBC patients receiving chemotherapy Receives: Behavioral: ED and quality of life assessment | |
| Cohort C (HR+/HER2-) | HR+/HER2- mBC patients receiving Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor + endocrine therapy Receives: Behavioral: ED and quality of life assessment | |
| Cohort D (HER2+) | HER2+ mBC patients receiving chemotherapy + trastuzumab and pertuzumab Receives: Behavioral: ED and quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (5)
Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D
Time from T0 (Cycle 1 Day 1) to disease progression or death
Measured: 2 years
Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1)
Time from T0 (Cycle 1 Day 1) to disease progression or death
Measured: 2 years
Objective response rate (ORR), according to the presence of ED at T0 and T1
Number of partial response or complete response achieved
Measured: 2 years
Quality of life evaluation
Completion of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC-QLQ-C30 (minimum value: 1, maximum value: 4 - higher scores mean a greater agreement with the statement)
Measured: 3 months
Fear of cancer progression evaluation
Completion of Fear of Progression Questionnaire (FoP Q) (minimum value: 1, maximum value: 5 - higher total score reflects a higher level of fear of disease progression)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start25 Jun 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, MD, PhD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994377
- Sponsor's protocol ID
- L2 - 311
- Other IDs
- UID 4907
- Acronym
- EIRENE
- Status last verified
- Jun 2026
- First submitted
- 20 May 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06994377
- Acronym / sponsor ID
- EIRENE / L2 - 311
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Emotional Distress, First Line Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Metastatic breast cancer (mBC) is the most incident and prevalent cancer in the world and, according to a recent meta-analysis, 50% of patients with BC report emotional distress (ED).
In patients with cancer, ED negatively impacts treatment adherence, ability to self-manage the physical and emotional consequences of cancer symptoms and treatment-related adverse events, and overall quality of life. ED has been shown to directly affect treatment outcomes in patients with breast cancer, with studies demonstrating that psychological well-being plays a critical role in therapeutic success.
Furthermore, recent studies showed that baseline ED is associated with a lower efficacy of immunotherapy in patients with non-small cell lung cancer (NSCLC) or melanoma.
Few data about the impact of ED on treatment efficacy in patients with mBC are available. In the first line setting patients receive endocrine therapy, chemotherapy, immunotherapy and/or targeted therapy according to the disease subtype. These agents display different mechanisms of action, which involve the immune system at different levels. However, the role of ED on the efficacy of these treatments according to the BC subtype is unknown.
Aim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A (HR-/HER2-, PD-L1+) | – | Behavioral: ED and quality of life assessmentTriple-negative Programmed Cell Death Ligand 1 (PD-L1)+ mBC patients receiving chemotherapy with immune checkpoint inhibitors (ICIs) |
| Cohort B (HR-/HER2-, PD-L1-) | – | Behavioral: ED and quality of life assessmentTriple-negative PD-L1- mBC patients receiving chemotherapy |
| Cohort C (HR+/HER2-) | – | Behavioral: ED and quality of life assessmentHR+/HER2- mBC patients receiving Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor + endocrine therapy |
| Cohort D (HER2+) | – | Behavioral: ED and quality of life assessmentHER2+ mBC patients receiving chemotherapy + trastuzumab and pertuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mBC eligible for standard 1st line treatment
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED and quality of life assessmentPatients will undergo ED and quality of life assessments through specific questionnaires completion | Behavioural | Cohort A (HR-/HER2-, PD-L1+), Cohort B (HR-/HER2-, PD-L1-), Cohort C (HR+/HER2-), Cohort D (HER2+) |
Primary outcome
Progression-free survival (PFS), according to the presence of ED at T0, in cohort A
Time frame: 2 years
Time from T0 (Cycle 1 Day 1) to disease progression or death
5 secondary outcomes
Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D
Time frame: 2 years
Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1)
Time frame: 2 years
Objective response rate (ORR), according to the presence of ED at T0 and T1
Time frame: 2 years
Quality of life evaluation
Time frame: 3 months
Fear of cancer progression evaluation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriella Pravettoni, MD, PhD principal investigator
European Istitute of Oncology
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by European Institute of Oncology at 37 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Pravettoni, MD, PhD (+39 0257489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS), according to the presence of ED at T0, in cohort A (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.