RecruitingNCT06994377
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
Sponsor
European Institute of Oncology
Enrollment
1,000 participants
Start Date
Jun 25, 2025
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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
Exclusion Criteria5
- 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
Interventions
BEHAVIORALED and quality of life assessment
Patients will undergo ED and quality of life assessments through specific questionnaires completion
Locations(37)
View Full Details on ClinicalTrials.gov
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NCT06994377
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