NCT06994377Recruiting
Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 20 May 2025
- Start date
- 25 Jun 2025
- Primary completion date
- Jun 2029
- Lead sponsor
- European Institute of Oncology
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06994377
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 25 Jun 2025 to the primary completion date, Jun 2029
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of another malignancy in the previous 3 years
- Ongoing treatment with antidepressant and/or anxiolytic drugs
Other illness
- Pre-existing severe psychiatric disorders or other conditions that could impair the ability to provide informed consent
Other
- Inability to complete questionnaires
- Symptomatic brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedali Riuniti di Ancona Coordinator of this site? Confirm its status | Ancona | Italy | Not yet recruiting |
| CRO (Centro di Riferimento Oncologico) Coordinator of this site? Confirm its status | Aviano | Italy | Not yet recruiting |
| Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata Coordinator of this site? Confirm its status | Bagno a Ripoli | Italy | Recruiting |
| IRCCS Istituto Tumori Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Not yet recruiting |
| Asst Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Not yet recruiting |
| ASST Spedali Civili Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Ospedale A. Perrino Coordinator of this site? Confirm its status | Brindisi | Italy | Not yet recruiting |
| ASST della Valle Olona Coordinator of this site? Confirm its status | Busto Arsizio | Italy | Not yet recruiting |
| Ospedale Valduce Coordinator of this site? Confirm its status | Como | Italy | Not yet recruiting |
| Ospedale Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Not yet recruiting |
| AOU Gaetano Martino di Messina Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
| European Institute of Oncology Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Ospedale San Giuseppe MultiMedica Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Policlinico di Milano Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Not yet recruiting |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Ospedale Maggiore di Novara Coordinator of this site? Confirm its status | Novara | Italy | Not yet recruiting |
| Policlinico Universitario Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Not yet recruiting |
| Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Not yet recruiting |
| Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano Coordinator of this site? Confirm its status | Prato | Italy | Recruiting |
| Ospedale "Infermi" Coordinator of this site? Confirm its status | Rimini | Italy | Not yet recruiting |
| Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria di Sassari Coordinator of this site? Confirm its status | Sassari | Italy | Recruiting |
| ASL CN2 - Ospedale Michele e Pietro Ferrero Coordinator of this site? Confirm its status | Verduno | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Not yet recruiting |
| Ospedale Sacro Cuore Don Calabria - Negrar Coordinator of this site? Confirm its status | Verona | Italy | Not yet recruiting |
| ASST Brianza Coordinator of this site? Confirm its status | Vimercate | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.