Clinical trial NCT06994377: Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
Official title: The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer
Emotional Distress
First Line Therapy
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mBC eligible for standard 1st line treatment

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 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.

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

Primary outcomes:
measure: Progression-free survival (PFS), according to the presence of ED at T0, in cohort A
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D
timeFrame: 2 years
measure: Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1)
timeFrame: 2 years
measure: Objective response rate (ORR), according to the presence of ED at T0 and T1
timeFrame: 2 years
measure: Quality of life evaluation
timeFrame: 3 months
measure: Fear of cancer progression evaluation
timeFrame: 3 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona
city: Aviano
country: Italy
facility: CRO (Centro di Riferimento Oncologico)
city: Bagno A Ripoli
country: Italy
facility: Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Brescia
country: Italy
facility: ASST Spedali Civili
city: Brindisi
country: Italy
facility: Ospedale A. Perrino
city: Busto Arsizio
country: Italy
facility: ASST della Valle Olona
city: Como
country: Italy
facility: Ospedale Valduce
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: AOU Gaetano Martino di Messina
city: Milan
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milan
country: Italy
facility: Ospedale Niguarda
city: Milan
country: Italy
facility: Ospedale San Giuseppe MultiMedica
city: Milan
country: Italy
facility: Policlinico di Milano
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
city: Novara
country: Italy
facility: Ospedale Maggiore di Novara
city: Palermo
country: Italy
facility: Policlinico Universitario Paolo Giaccone
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Prato
country: Italy
facility: Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano
city: Rimini
country: Italy
facility: Ospedale Infermi
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli IRCCS
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria di Sassari
city: Verduno
country: Italy
facility: ASL CN2 - Ospedale Michele e Pietro Ferrero
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Verona
country: Italy
facility: Ospedale Sacro Cuore Don Calabria - Negrar
city: Vimercate
country: Italy
facility: ASST Brianza
Study officials:
affiliation: European Istitute of Oncology
name: Gabriella Pravettoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: