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Набор скоро начнётся NCT06499168

Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Наблюдательное Locally Advanced 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: neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery.
Кому может быть актуально
Состояния в реестре: Locally Advanced 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

CD10 as a Prognostic and Predictive Factor to Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer

Обзор

Female breast cancer is the second leading cause of global cancer incidence in 2022 and the fourth leading cause of cancer mortality worldwide. Breast cancer (BC) remains the most prevalent cancer diagnosis among women; nevertheless, considerable advancements in diagnostics and treatment approaches have significantly enhanced patient outcomes. In locally advanced cases, primary systemic chemotherapy is often indicated, and the choice of treatment is influenced by the evaluation of routine prognostic and predictive factors. Neoadjuvant chemotherapy (NCT) has emerged as a valuable approach to enhance the quality of life ,disease-free and overall survival for early and locally advanced BC patients Approximately 30% of BC cases achieve a pathological complete response (pCR) following NCT. Unfortunately, proper quantification of estrogen- and progesterone receptors (ER and PR), human epidermal growth factor receptor-2 (HER2/Neu) and proliferation markers are insufficient to predict chemosensitivity of some breast tumors , so the identification of these cases during routine pathological examination of biopsy specimens could be especially useful in planning the oncotherapeutic strategy for proper patient management. CD10, has recently gained attention as an independent diagnostic and prognostic marker in various solid tumors with significant metastatic potential. This molecule has been shown to play a role in cell adhesion, migration, and extracellular matrix remodelling. A strong CD10 expression has been linked to hormone receptor negativity and HER-2/neu overexpression in breast cancer. Moreover, the dynamics of stromal CD10 expression undergo changes during neoadjuvant anthracycline-based chemotherapy. Recent research, has presented compelling data indicating that CD10 expression may serve as a predictive marker for the impact of neoadjuvant chemotherapy in breast cancer patients.

Подробное описание

Formalin fixed paraffin embedded tissue specimen of the baseline TCNB of locally advanced breast cancer will be obtained from pathology laboratory, Pathology Department, Assiut University.

* Histological diagnosis of H\&E stained sections will be confirmed. * Immunohistochemical staining for CD10 . * Baseline clinicopathological features of patients who will receive neoadjuvant chemotherapy will be collected from patients' records. * Correlation between CD10 expression and the baseline clinicopathological features with the response to neoadjuvant chemotherapy.

Вмешательства

  • Препарат neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery
    In locally advanced breast cancer patients who will receive neoadjuvant chemotherapy formalin fixed paraffin embedded tissue specimen of the baseline TCNB of locally advanced breast cancer will be obtained from pathology laboratory, Pathology Department, Assiut University. * Histological diagnosis of H\&E stained sections will be confirmed. * Immunohistochemical staining for CD10 . * Baseline clinicopathological features of patients who will receive neoadjuvant chemotherapy will be collected fr

Первичные конечные точки

  • The response to neoadjuvant chemotherapy in locally advanced breast cancer in relation to CD10 expression [Срок оценки: 6 months]
Вторичные конечные точки (2)
  • progression free survival (PFS) [Срок оценки: 2 years]
  • Overall survival (OS) [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Patients above 18 years
  • Pathologically proven breast carcinoma
  • Locally advanced breast cancer

Критерии исключения

  • Patients below 18 years.
  • Patients with metastatic disease
  • Patients with second primary cancer
  • Patients ineligible for chemotherapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06499168 · response to NAC in LABC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗