Clinical trial · Observational
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
NCT06994377CI-TRIAL-00114987EIRENErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ED and quality of life assessment | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Cohort A (HR-/HER2-, PD-L1+)
- description
- Triple-negative Programmed Cell Death Ligand 1 (PD-L1)+ mBC patients receiving chemotherapy with immune checkpoint inhibitors (ICIs)
- interventionNames
- Behavioral: ED and quality of life assessment
- label
- Cohort B (HR-/HER2-, PD-L1-)
- description
- Triple-negative PD-L1- mBC patients receiving chemotherapy
- interventionNames
- Behavioral: ED and quality of life assessment
- label
- Cohort C (HR+/HER2-)
- description
- HR+/HER2- mBC patients receiving Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor + endocrine therapy
- interventionNames
- Behavioral: ED and quality of life assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. cohort A (HR-/HER2-, PD-L1+): pembrolizumab or atezolizumab + chemotherapy 2. cohort B (HR-/HER2-, PD-L1-): chemotherapy 3. cohort C (HR+/HER2-): CDK4/6 inhibitor + endocrine therapy 4. 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.