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Recruiting
NCT06994377
Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
Conditions: Metastatic Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: European Institute of Oncology
Location: Ospedali Riuniti di Ancona Ancona
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 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
Source: ClinicalTrials.gov (NCT06994377). StuddyBuddy aggregates publicly available trial information.