Набор по приглашению NCT04098640

Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer

Без фазы С лечением 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: FoundationOne CDx.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: 19 лет — 50 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: South Korea
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

Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)

Обзор

Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western. Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients. The primary objective of this study is to elucidate the genetic characteristic of young (\<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.

Подробное описание

Secondary Objective(s):

1. To evaluate the prognostic and predictive role of tumor mutation burden. 2. To reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including DNA damage repair (DDR) molecules and various immune modulating molecules including PD-L1, PD-1, IDO, and OX40). 3. Compare molecular characteristics of breast cancer according to age groups (\<35 years vs. 35-50 years). 4. To offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). In addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).

Вмешательства

Генная терапия FoundationOne CDx
FoundationOne CDx will be performed using archival tumor tissue

Первичные конечные точки

Genetic characteristic of young (<50 years of age) Korean patients with metastatic breast cancer. [Срок оценки: After the end of patient enrollment]

Вторичные конечные точки (4)

Evaluate the prognostic and predictive role of tumor mutation burden [Срок оценки: After the end of patient enrollment]
Reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins. [Срок оценки: After the end of patient enrollment]
Compare molecular characteristics of breast cancer according to age groups. [Срок оценки: After the end of patient enrollment]
To offer genomic profiling guided therapy to patients To explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data). [Срок оценки: After the end of patient enrollment]

Критерии участия

Критерии включения

Patients between 19 - 50 years of age on the day of signing informed consent.
Able to provide written informed consent for voluntary participation in the trial.
With metastatic breast cancer
Willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory. (with at least 10 unstained slides and 1 H\&E slide)