Emotional distress and first-line treatment outcomes in metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort study enrolling adults with confirmed metastatic breast cancer who are starting first-line systemic therapy. Participants are grouped by disease subtype and planned treatment (chemotherapy, endocrine+CDK4/6 inhibitor, anti-HER2 regimens, or chemo ± immunotherapy) and complete baseline questionnaires measuring emotional distress and quality of life. Clinical outcomes such as response, progression, and survival will be tracked and compared between patients with and without baseline emotional distress. Patients with severe psychiatric disorders or inability to complete questionnaires are excluded, and follow-up occurs at routine clinical visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata
  Bagno a Ripoli, Italy Recruiting
• AOU Gaetano Martino di Messina
  Messina, Italy Recruiting
• European Institute of Oncology
  Milan, Italy Recruiting
• Azienda Ospedaliero Universitaria Pisana
  Pisa, Italy Recruiting
• Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano
  Prato, Italy Recruiting
• Policlinico Universitario Agostino Gemelli IRCCS
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Gabriella Pravettoni, MD, PhD — European Istitute of Oncology
• Study coordinator: Gabriella Pravettoni, MD, PhD
• Email: gabriella.pravettoni@ieo.it
• Phone: +39 0257489731

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Personalized treatment after endocrine therapy failure in metastatic breast cancer

  The study tests whether using a patient’s fresh tumor sample to try different drugs outside the body can help pick the next therapy for hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on endocrine therapy.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07895160

• SSGJ-612 plus a HER2-targeted ADC in HR-positive, HER2-low metastatic breast cancer

  This phase II study tests whether adding SSGJ-612 to a HER2-targeted antibody-drug conjugate helps people with HR-positive, HER2-low or ultralow metastatic breast cancer.

  Recruiting Phase 2 Shenyang Sunshine Pharmaceutical Co., LTD. · Guangzhou, Guangdong · NCT07757230

• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

  This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.

  Recruiting Phase 2 Chengdu SciMount Pharmatech Co., Ltd. · Hefei, Anhui and 14 other locations · NCT07726342

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• T-DXd–based therapy followed by targeted HER2 blockade and endocrine therapy in first-line HER2+ / HR+ metastatic breast cancer

  This trial tests a sequence of therapies starting with T-DXd plus pertuzumab, then a maintenance phase with dual HER2 blockade, endocrine therapy, and CDK4/6 inhibitor, with a retreatment option of T-DXd if disease progresses.

  Recruiting at 5 sites Phase 3 Daiichi Sankyo · Columbia, Maryland and 4 other locations · NCT07683754

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.