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Does your mood affect cancer treatment? new study investigates

NCT ID NCT06994377

Knowledge-focused Sponsor: European Institute of Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether emotional distress (like anxiety or depression) affects how well first-line therapy works in people with metastatic breast cancer. Researchers will follow 1000 patients starting standard treatments based on their cancer type. The goal is to see if those with emotional distress have different outcomes, such as how long the cancer stays under control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with mBC eligible for standard 1st line treatment

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Gaetano Martino di Messina

    RECRUITING

    Messina, Italy

  • ASL CN2 - Ospedale Michele e Pietro Ferrero

    RECRUITING

    Verduno, Italy

  • ASST Brianza

    NOT_YET_RECRUITING

    Vimercate, Italy

  • ASST Fatebenefratelli Sacco

    NOT_YET_RECRUITING

    Milan, Italy

  • ASST Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, Italy

  • ASST Spedali Civili

    NOT_YET_RECRUITING

    Brescia, Italy

  • ASST della Valle Olona

    NOT_YET_RECRUITING

    Busto Arsizio, Italy

  • Azienda Ospedaliera Universitaria Federico II

    NOT_YET_RECRUITING

    Naples, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    NOT_YET_RECRUITING

    Verona, Italy

  • Azienda Ospedaliero Universitaria Pisana

    NOT_YET_RECRUITING

    Pisa, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, Italy

  • Azienda Ospedaliero Universitaria di Sassari

    RECRUITING

    Sassari, Italy

  • Azienda Ospedaliero-Universitaria di Modena

    NOT_YET_RECRUITING

    Modena, Italy

  • Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata

    RECRUITING

    Bagno a Ripoli, Italy

  • Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano

    RECRUITING

    Prato, Italy

  • CRO (Centro di Riferimento Oncologico)

    NOT_YET_RECRUITING

    Aviano, Italy

  • European Institute of Oncology

    RECRUITING

    Milan, 20141, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    NOT_YET_RECRUITING

    Milan, Italy

  • IRCCS Istituto Tumori Giovanni Paolo II

    NOT_YET_RECRUITING

    Bari, Italy

  • IRCCS Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    NOT_YET_RECRUITING

    Naples, Italy

  • Ospedale A. Perrino

    NOT_YET_RECRUITING

    Brindisi, Italy

  • Ospedale Careggi

    NOT_YET_RECRUITING

    Florence, Italy

  • Ospedale Infermi

    NOT_YET_RECRUITING

    Rimini, Italy

  • Ospedale Maggiore di Novara

    NOT_YET_RECRUITING

    Novara, Italy

  • Ospedale Niguarda

    NOT_YET_RECRUITING

    Milan, Italy

  • Ospedale Policlinico San Martino

    NOT_YET_RECRUITING

    Genova, Italy

  • Ospedale Sacro Cuore Don Calabria - Negrar

    NOT_YET_RECRUITING

    Verona, Italy

  • Ospedale San Giuseppe MultiMedica

    NOT_YET_RECRUITING

    Milan, Italy

  • Ospedale Valduce

    NOT_YET_RECRUITING

    Como, Italy

  • Ospedali Riuniti di Ancona

    NOT_YET_RECRUITING

    Ancona, Italy

  • Policlinico San Matteo

    NOT_YET_RECRUITING

    Pavia, Italy

  • Policlinico Umberto I

    NOT_YET_RECRUITING

    Rome, Italy

  • Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, Italy

  • Policlinico Universitario Campus Bio-Medico

    NOT_YET_RECRUITING

    Roma, Italy

  • Policlinico Universitario Paolo Giaccone

    NOT_YET_RECRUITING

    Palermo, Italy

  • Policlinico di Milano

    NOT_YET_RECRUITING

    Milan, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.