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Идёт набор NCT06994377

Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy

— Наблюдательное Metastatic Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ED and quality of life assessment.
Кому может быть актуально
Состояния в реестре: Metastatic Breast Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

Metastatic breast cancer (mBC) is the most incident and prevalent cancer in the world and, according to a recent meta-analysis, 50% of patients with BC report emotional distress (ED).

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.

Вмешательства

  • Поведенческое ED and quality of life assessment
    Patients will undergo ED and quality of life assessments through specific questionnaires completion

Первичные конечные точки

  • Progression-free survival (PFS), according to the presence of ED at T0, in cohort A [Срок оценки: 2 years]
Вторичные конечные точки (5)
  • Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D [Срок оценки: 2 years]
  • Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1) [Срок оценки: 2 years]
  • Objective response rate (ORR), according to the presence of ED at T0 and T1 [Срок оценки: 2 years]
  • Quality of life evaluation [Срок оценки: 3 months]
  • Fear of cancer progression evaluation [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • 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:
  • cohort A (HR-/HER2-, PD-L1+): pembrolizumab or atezolizumab + chemotherapy
  • cohort B (HR-/HER2-, PD-L1-): chemotherapy
  • cohort C (HR+/HER2-): CDK4/6 inhibitor + endocrine therapy
  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 37 центров
  • Ospedali Riuniti di Ancona — Ancona
  • CRO (Centro di Riferimento Oncologico) — Aviano
  • Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata — Bagno a Ripoli
  • IRCCS Istituto Tumori Giovanni Paolo II — Bari
  • ASST Papa Giovanni XXIII — Bergamo
  • ASST Spedali Civili — Brescia
  • Ospedale A. Perrino — Brindisi
  • ASST della Valle Olona — Busto Arsizio
  • … и ещё 29 центров

Идентификаторы

NCT: NCT06994377 · L2 - 311 · UID 4907

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗