NCT06994377 Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
| NCT ID | NCT06994377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Metastatic Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-06-25 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Gabriella Pravettoni, MD, PhD
PRINCIPAL INVESTIGATOR
European Istitute of Oncology
Frequently Asked Questions
Who can join the NCT06994377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06994377 currently recruiting?
Yes, NCT06994377 is actively recruiting participants. Contact the research team at gabriella.pravettoni@ieo.it for enrollment information.
Where is the NCT06994377 trial being conducted?
This trial is being conducted at Ancona, Italy, Aviano, Italy, Bagno a Ripoli, Italy, Bari, Italy and 11 additional locations.
Who is sponsoring the NCT06994377 clinical trial?
NCT06994377 is sponsored by European Institute of Oncology. The principal investigator is Gabriella Pravettoni, MD, PhD at European Istitute of Oncology. The trial plans to enroll 1,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.