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Идёт набор NCT04703244

Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer

— Наблюдательное Breast Cancer Residual

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: chemotherapy or endocrine therapy for breast cancer.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Residual. 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
США
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

Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy

Обзор

Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (\>50%) risk of future life-threatening recurrences and death.

Подробное описание

This study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. We will use the blood and tissue for future studies. These studies will try to find ways to treat future breast cancer patients.

Because there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. Tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it.

Blood samples will be used to look at measurements of biomarkers to see how this cancer is different and seek new ways to identify and treat it.

Вмешательства

  • Процедура chemotherapy or endocrine therapy for breast cancer
    Collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed.

Первичные конечные точки

  • Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy [Срок оценки: Up to 12 months until death or a maximum of 20 years post registration]
Вторичные конечные точки (7)
  • Utilize patient derived xenografts (PDX) models to study new drugs/drug combinations [Срок оценки: Up to 12 months until death or a maximum of 20 years post registration]
  • Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance [Срок оценки: Up to 12 months until death or a maximum of 20 years post registration]
  • Correlate the association between Cell Free DNA (cfDNA), Circulating Tumor Cells (CTCs) and circulating immune cell subpopulations (as measured by CyTOF) with residual cancer burden [Срок оценки: Up to 12 months until death or a maximum of 20 years post registration]
  • Correlate the association between Cell Free DNA (cfDNA) with residual cancer burden [Срок оценки: Up to 12 months until death or a maximum of 20 years post registration]
  • Correlate the association between Circulating Tumor Cells (CTCs) with residual cancer burden [Срок оценки: Up to 12 months until death or a maximum of 20 years post registration]
  • Correlate the association between circulating immune cell subpopulations (as measured by Cytometry by time-of-flight (CyTOF) with residual cancer burden [Срок оценки: Up to 12 months until death or a maximum of 20 years post registration]
  • Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response [Срок оценки: Up to 12 months until death or a maximum of 20 years post registration]

Критерии участия

Критерии включения

  • Age ≥18 years.
  • Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.
  • Surgically resectable disease following neoadjuvant systemic treatment.
  • At least one of the following must be true:
  • Received at least 2 weeks of neoadjuvant endocrine therapy
  • Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging
  • Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination
  • Provide written informed consent.
  • Willing to return to enrolling institution for breast cancer surgery.
  • Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
  • Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
  • Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic.

Критерии исключения

  • Ineligible for surgery.
  • History of prior malignancy <3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).

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

США · 1 центр
  • Mayo Clinic — Rochester

Идентификаторы

NCT: NCT04703244 · MC1933

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗