Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
NCT ID: NCT06994377
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2025-06-25
2029-06-30
Brief Summary
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Aim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A (HR-/HER2-, PD-L1+)
Triple-negative Programmed Cell Death Ligand 1 (PD-L1)+ mBC patients receiving chemotherapy with immune checkpoint inhibitors (ICIs)
ED and quality of life assessment
Patients will undergo ED and quality of life assessments through specific questionnaires completion
Cohort B (HR-/HER2-, PD-L1-)
Triple-negative PD-L1- mBC patients receiving chemotherapy
ED and quality of life assessment
Patients will undergo ED and quality of life assessments through specific questionnaires completion
Cohort C (HR+/HER2-)
HR+/HER2- mBC patients receiving Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor + endocrine therapy
ED and quality of life assessment
Patients will undergo ED and quality of life assessments through specific questionnaires completion
Cohort D (HER2+)
HER2+ mBC patients receiving chemotherapy + trastuzumab and pertuzumab
ED and quality of life assessment
Patients will undergo ED and quality of life assessments through specific questionnaires completion
Interventions
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ED and quality of life assessment
Patients will undergo ED and quality of life assessments through specific questionnaires completion
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to complete questionnaires
* Presence of another malignancy in the previous 3 years
* Symptomatic brain metastases
* Ongoing treatment with antidepressant and/or anxiolytic drugs
18 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Gabriella Pravettoni, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
European Istitute of Oncology
Locations
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Ospedali Riuniti di Ancona
Ancona, , Italy
CRO (Centro di Riferimento Oncologico)
Aviano, , Italy
Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata
Bagno a Ripoli, , Italy
IRCCS Istituto Tumori Giovanni Paolo II
Bari, , Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
ASST Spedali Civili
Brescia, , Italy
Ospedale A. Perrino
Brindisi, , Italy
ASST della Valle Olona
Busto Arsizio, , Italy
Ospedale Valduce
Como, , Italy
Ospedale Careggi
Florence, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
AOU Gaetano Martino di Messina
Messina, , Italy
European Institute of Oncology
Milan, , Italy
ASST Fatebenefratelli Sacco
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Ospedale Niguarda
Milan, , Italy
Ospedale San Giuseppe MultiMedica
Milan, , Italy
Policlinico di Milano
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , Italy
Ospedale Maggiore di Novara
Novara, , Italy
Policlinico Universitario Paolo Giaccone
Palermo, , Italy
Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano
Prato, , Italy
Ospedale Infermi
Rimini, , Italy
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Policlinico Umberto I
Rome, , Italy
Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Azienda Ospedaliero Universitaria di Sassari
Sassari, , Italy
ASL CN2 - Ospedale Michele e Pietro Ferrero
Verduno, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Ospedale Sacro Cuore Don Calabria - Negrar
Verona, , Italy
ASST Brianza
Vimercate, , Italy
Countries
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Central Contacts
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Facility Contacts
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Rossana Berardi
Role: primary
Fabio Puglisi, MD
Role: primary
Carlotta Bacci, MD
Role: primary
Nicola Silvestris, MD
Role: primary
Alberto Zambelli, MD
Role: primary
Rebecca Pedersini, MD
Role: primary
Saverio Cinieri, MD
Role: primary
Maria Marconi, MD
Role: primary
Giovanni Scognamiglio, MD
Role: primary
Icro Meattini, MD
Role: primary
Lucia Del Mastro, MD
Role: primary
Massimilano Berretta, MD
Role: primary
Gabriella Pravettoni, MD
Role: primary
Nicla La Verde, MD
Role: primary
Claudio Vernieri, MD
Role: primary
Giulia Viale, MD
Role: primary
Salvatore Siena, MD
Role: primary
Pier Francesco Ferrucci, MD
Role: primary
Ornella Garrone, MD
Role: primary
Angela Toss, MD
Role: primary
Roberto Bianco, MD
Role: primary
Michelino De Laurentiis, MD
Role: primary
Alessandra Gennari, MD
Role: primary
Antonio Russo, MD
Role: primary
Paolo Pedrazzoli, MD
Role: primary
Chiara Cremolini, MD
Role: primary
Carmelo Bengala, MD
Role: primary
Laura Biganzoli, MD
Role: primary
Lorenzo Gianni, MD
Role: primary
Francesco Pantano, MD
Role: primary
Andrea Botticelli, MD
Role: primary
Alessandra Fabi, MD
Role: primary
Valeria Sanna, MD
Role: primary
Veronica Prati, MD
Role: primary
Elena Fiorio, MD
Role: primary
Stefania Gori, MD
Role: primary
Paola Tagliabue, MD
Role: primary
Other Identifiers
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UID 4907
Identifier Type: OTHER
Identifier Source: secondary_id
L2 - 311
Identifier Type: -
Identifier Source: org_study_id
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