Status:
RECRUITING
Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
Lead Sponsor:
European Institute of Oncology
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 ...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06994377
Start Date
June 25 2025
End Date
June 1 2029
Last Update
December 4 2025
Active Locations (37)
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1
Ospedali Riuniti di Ancona
Ancona, Italy
2
CRO (Centro di Riferimento Oncologico)
Aviano, Italy
3
Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata
Bagno a Ripoli, Italy
4
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy