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.
Age over 18 years
Confirmed histological diagnosis of breast cancer
No prior treatment for advanced/metastatic cancer
cohort A (HR-/HER2-, PD-L1+): pembrolizumab or atezolizumab + chemotherapy
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
Patients with mBC eligible for standard 1st line treatment
Cohort
Prospective
ED and quality of life assessment
BehavioralPatients will undergo ED and quality of life assessments through specific questionnaires completion
Progression-free survival (PFS), according to the presence of ED at T0, in cohort A
Time from T0 (Cycle 1 Day 1) to disease progression or death
Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D
Time from T0 (Cycle 1 Day 1) to disease progression or death
Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1)
Time from T0 (Cycle 1 Day 1) to disease progression or death
Objective response rate (ORR), according to the presence of ED at T0 and T1
Number of partial response or complete response achieved
Quality of life evaluation
Completion of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC-QLQ-C30 (minimum value: 1, maximum value: 4 - higher scores mean a greater agreement with the statement)
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