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Recruiting NCT06994377

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

— Observational Metastatic Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ED and quality of life assessment.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 with cancer, ED negatively impacts treatment adherence, ability to self-manage the physical and emotional consequences of cancer symptoms and treatment-related adverse events, and overall quality of life. ED has been shown to directly affect treatment outcomes in patients with breast cancer, with studies demonstrating that psychological well-being plays a critical role in therapeutic success.

Furthermore, recent studies showed that baseline ED is associated with a lower efficacy of immunotherapy in patients with non-small cell lung cancer (NSCLC) or melanoma.

Few data about the impact of ED on treatment efficacy in patients with mBC are available. In the first line setting patients receive endocrine therapy, chemotherapy, immunotherapy and/or targeted therapy according to the disease subtype. These agents display different mechanisms of action, which involve the immune system at different levels. However, the role of ED on the efficacy of these treatments according to the BC subtype is unknown.

Aim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.

Interventions

  • Behavioral ED and quality of life assessment
    Patients will undergo ED and quality of life assessments through specific questionnaires completion

Primary outcome measures

  • Progression-free survival (PFS), according to the presence of ED at T0, in cohort A [Time frame: 2 years]
Secondary outcome measures (5)
  • Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D [Time frame: 2 years]
  • Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1) [Time frame: 2 years]
  • Objective response rate (ORR), according to the presence of ED at T0 and T1 [Time frame: 2 years]
  • Quality of life evaluation [Time frame: 3 months]
  • Fear of cancer progression evaluation [Time frame: 3 months]

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:
  • 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 37 centers
  • Ospedali Riuniti di Ancona — Ancona
  • CRO (Centro di Riferimento Oncologico) — Aviano
  • Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata — Bagno a Ripoli
  • IRCCS Istituto Tumori Giovanni Paolo II — Bari
  • ASST Papa Giovanni XXIII — Bergamo
  • ASST Spedali Civili — Brescia
  • Ospedale A. Perrino — Brindisi
  • ASST della Valle Olona — Busto Arsizio
  • … and 29 more centers

Identifiers

NCT: NCT06994377 · L2 - 311 · UID 4907

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗