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Идёт набор NCT06709651

Microbiome Immunotherapy Neoadjuvant Assessment

— Наблюдательное Triple Negative 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Triple Negative 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
Ирландия
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

Prospective Evaluation of the Breast Microbiome and Tumor Microenvironment-related Biomarkers of Response to Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer

Обзор

Predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to help tailor treatment recommendations for patients with early-stage TNBC. Tumour-associated microbiota in primary breast tumours represent promising and novel candidate biomarkers modulators of the efficacy of therapies for patients with TNBC. It has been shown that microbes colonizing breast tumours can modulate the efficacy of commonly used drugs and that the microbiome of breast tissue biopsies could represent a new biomarker. Data on the microbiome of patients with cancer indicate the potential for a new class of bacteria-based oncological biomarkers, for exploitation in precision oncology.

Первичные конечные точки

  • To evaluate the breast cancer microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (6)
  • To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and pathologic complete response [Срок оценки: Through study completion, an average of 1 year]
  • To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and event-free survival [Срок оценки: Through study completion, an average of 1 year]
  • To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and overall survival [Срок оценки: Through study completion, an average of 1 year]
  • To determine the relationship between the breast cancer microbiome and tumor infiltrating leukocytes (TILs) [Срок оценки: Through study completion, an average of 1 year]
  • To determine the relationship between the breast cancer microbiome and programmed death ligand -1 (PDL-1) [Срок оценки: Through study completion, an average of 1 year]
  • To evaluate the gut microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Be willing and able to provide written informed consent for the trial in accordance with national/local guidelines.
  • Be a male or female subject 18 years of age on day of signing informed consent.
  • Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:

HER2 negative in primary tumour pre-treatment by local pathology assessed according current ASCO/CAP guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+.

ER and PR negative in primary tumour pre-treatment defined as < 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.

  • Unresected, untreated breast cancer planned to undergo neoadjuvant systemic therapy, that meets one of the following clinical stages (see Appendix A):

o T2, T3, or T4a-d lesion, any N, M0

  • Be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure).

Критерии исключения

  • Patients who are pregnant or breast-feeding
  • Current use of any investigational agents
  • History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Ирландия · 1 центр
  • Cork University Hospital — Cork

Идентификаторы

NCT: NCT06709651 · 23120

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗