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Идёт набор NCT07563595

Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer

— Наблюдательное 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: Elacestrant, Standard of care (Investigator Choice).
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study

Обзор

The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and/or metastatic ER+ HER2- ESR1-mutated breast cancer and second line treatment with elacestrant according to SmPC (Summary of product characteristics) in a real-world setting.

Вмешательства

  • Препарат Elacestrant
    According to the Summary of Product Characteristics (SmPC)
  • Препарат Standard of care (Investigator Choice)
    Treatment decision of investigator

Первичные конечные точки

  • Change from baseline in EORTC global health scale [Срок оценки: From Time of enrollment until month 11]
Вторичные конечные точки (12)
  • Time to deterioration in global health scale (EORTC QLQ-C30) [Срок оценки: From Time of enrollment until month 11]
  • Time to deterioration in functional scores (EORTC QLQ-C30) [Срок оценки: From Time of enrollment until month 11]
  • Time to deterioration in symptom scores (EORTC QLQ-C30) [Срок оценки: From Time of enrollment until month 11]
  • Change from baseline in functional and symptom scores [Срок оценки: From Time of enrolment until up to 11 months after enrolment.]
  • Change from baseline in visual analogue scale (VAS) [Срок оценки: From Time of enrollment until month 11.]
  • Change from baseline in index value [Срок оценки: From Time of enrollment until month 11.]
  • Change from baseline in all scales of EQ-5D-5L [Срок оценки: From Time of enrollment until month 11.]
  • Prevalence of ESR1 mutation [Срок оценки: Baseline]
  • Drug safety: Frequency [Срок оценки: From time of treatment start until 30 days after end of elacestrant treatment]
  • Drug safety: Incidence of adverse events [Срок оценки: From time of treatment start until 30 days after end of elacestrant treatment]
  • Drug safety: Change from baseline in AST (Aspartate Aminotransferase) [Срок оценки: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)]
  • Drug safety: Change from baseline in ALT (Alanine Aminotransferase) [Срок оценки: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)]

Критерии участия

Критерии включения

  • Signed and dated informed consent form
  • Postmenopausal women
  • Age ≥18 years
  • Eastern Cooperative Oncology Group Performance Status (ECOG) < 2
  • Locally advanced and/or metastatic ER+ HER2- breast cancer
  • Histologically proven ER positivity (defined as ≥1% staining by immunohistochemistry (IHC))
  • Histologically proven HER2 negativity (defined as a IHC0 or IHC1+ score by IHC or a negative result by in situ hybridization (ISH), optionally combined with a IHC2+ score)
  • Disease progression following first line ET + CDKi
  • No more than one prior ET line in the advanced/metastatic setting and intention for 2nd-line treatment with elacestrant according to current elacestrant SmPC as assessed by the treating physician (ESR1 testing can be done after inclusion)
  • For patients with proven ESR1mut: Study inclusion the latest 2 weeks after start of elacestrant treatment

Критерии исключения

  • Prior chemotherapy in the advanced/metastatic setting
  • Contraindications according to elacestrant SmPC, except for ESR1 test result for patients included prior to ESR1 testing.
  • Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial (except follow-up phase)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Германия · 3 центра
  • Praxis für interdisziplinäre Onkologie & Hämatologie — Freiburg im Breisgau
  • St. Louise Frauen- und Kinderklinik — Paderborn
  • Gemeinschaftspraxis für Hämatologie und Onkologie — Ravensburg

Идентификаторы

NCT: NCT07563595 · IOM-090506

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗