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Emotional distress and first-line treatment outcomes in metastatic breast cancer

The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study

Observational European Institute of Oncology · NCT06994377

This study will see if emotional distress at the start of treatment changes how well first-line therapies work for people with metastatic breast cancer.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorEuropean Institute of Oncology Academic / other
Drugs / interventionspembrolizumab, atezolizumab, trastuzumab, pertuzumab, chemotherapy, immunotherapy
Locations37 sites (Ancona and 36 other locations)
Trial IDNCT06994377 on ClinicalTrials.gov

What this trial studies

This is an observational cohort study enrolling adults with confirmed metastatic breast cancer who are starting first-line systemic therapy. Participants are grouped by disease subtype and planned treatment (chemotherapy, endocrine+CDK4/6 inhibitor, anti-HER2 regimens, or chemo ± immunotherapy) and complete baseline questionnaires measuring emotional distress and quality of life. Clinical outcomes such as response, progression, and survival will be tracked and compared between patients with and without baseline emotional distress. Patients with severe psychiatric disorders or inability to complete questionnaires are excluded, and follow-up occurs at routine clinical visits.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed metastatic breast cancer who have not received prior treatment for advanced disease, have measurable disease, and can give informed consent and complete questionnaires are ideal candidates.

Not a fit: Patients with pre-existing severe psychiatric disorders, inability to complete questionnaires, prior recent malignancies, or who cannot attend participating centers are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could identify patients whose emotional distress is linked to poorer treatment outcomes and support targeting psychosocial interventions to improve care.

How similar studies have performed: Prior observational work has linked baseline emotional distress to lower immunotherapy efficacy in lung cancer and melanoma, but direct data in metastatic breast cancer are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Ancona and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Breast CancerEmotional DistressFirst Line Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.