Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy

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

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

Conditions3

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