The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study

Study examines emotional distress impact on first-line treatment for metastatic breast cancer.

NCT: NCT06994377 · Status: RECRUITING · Phase: N/A · Sponsor: European Institute of Oncology · Started: 2025-06-25 · Est. Completion: 2029-06

Plain English Summary

Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy is a Not Applicable clinical trial sponsored by European Institute of Oncology studying Metastatic Breast Cancer. This study looks at how emotional distress affects the success of initial treatments for metastatic breast cancer. It is for patients diagnosed with metastatic breast cancer who are about to start their first treatment. Participation involves completing questionnaires about your emotional well-being and quality of life. There are no alternative treatments offered within this study; it observes standard care. The trial aims to enroll 1000 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and over with a confirmed diagnosis of breast cancer. Patients who have not received prior treatment for advanced or metastatic cancer. Individuals starting specific first-line therapies based on their cancer subtype. Patients must have measurable disease and be able to give informed consent. This trial is studying Metastatic Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

Progression-free survival means how long patients live without their cancer getting worse, and this study will see if emotional distress affects that timeframe. The specific primary outcome measures are: Progression-free survival (PFS), according to the presence of ED at T0, in cohort A (2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it aims to understand how emotional well-being influences treatment outcomes in metastatic breast cancer, addressing a gap in current knowledge. This research targets Metastatic Breast Cancer, where improved treatment options are needed.

Investor Insight

This observational study focuses on a significant patient population, potentially influencing how supportive care is integrated into standard mBC treatment, which could impact the market for supportiv The large enrollment target of 1000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific first-line treatment you will receive and how emotional well-being is monitored. Be prepared to answer questionnaires regularly about your feelings and quality of life. Your day-to-day involvement will primarily be completing these assessments alongside your standard medical care. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06994377?

NCT06994377 is a Not Applicable OBSERVATIONAL study titled "Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy." It is currently recruiting and is sponsored by European Institute of Oncology. The trial targets enrollment of 1000 participants.

What conditions does NCT06994377 study?

This trial investigates treatments for Metastatic Breast Cancer. The primary condition under study is Metastatic Breast Cancer.

What treatments are being tested in NCT06994377?

The interventions being studied include: ED and quality of life assessment (BEHAVIORAL). Patients will undergo ED and quality of life assessments through specific questionnaires completion

What does Not Applicable mean for NCT06994377?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06994377?

This trial is currently "Recruiting." It started on 2025-06-25. The estimated completion date is 2029-06.

Who is sponsoring NCT06994377?

NCT06994377 is sponsored by European Institute of Oncology. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06994377?

The trial aims to enroll 1000 participants. The trial is currently recruiting and accepting new participants.

How is NCT06994377 designed?

This is a observational study.

What are the primary outcomes being measured in NCT06994377?

The primary outcome measures are: Progression-free survival (PFS), according to the presence of ED at T0, in cohort A (2 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06994377 being conducted?

This trial is being conducted at 20 sites, including Ancona; Aviano; Bagno a Ripoli; Bari and 16 more sites (Italy).

Where can I find official information about NCT06994377?

The official record for NCT06994377 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06994377. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06994377 testing in simple terms?

This study looks at how emotional distress affects the success of initial treatments for metastatic breast cancer. It is for patients diagnosed with metastatic breast cancer who are about to start their first treatment.

Why is this trial significant?

This trial is important because it aims to understand how emotional well-being influences treatment outcomes in metastatic breast cancer, addressing a gap in current knowledge.

What are the potential risks of participating in NCT06994377?

Potential side effects are related to the standard cancer treatments being administered, not the study itself. Some patients might experience discomfort or fatigue from completing questionnaires. Exclusion criteria aim to ensure the study data is clear, meaning individuals with severe pre-existing mental health conditions or those unable to consent may not be eligible. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06994377?

Ask your doctor about the specific first-line treatment you will receive and how emotional well-being is monitored. Be prepared to answer questionnaires regularly about your feelings and quality of life. Your day-to-day involvement will primarily be completing these assessments alongside your standard medical care. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06994377 signal from an investment perspective?

This observational study focuses on a significant patient population, potentially influencing how supportive care is integrated into standard mBC treatment, which could impact the market for supportiv This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves completing questionnaires about your emotional well-being and quality of life. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.