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Идёт набор NCT05766410

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Фаза II С лечением Breast Cancer Hormone Receptor-positive Breast Cancer Hormone Therapy

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: Palbociclib, Ribociclib, Abemaciclib, Letrozole.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Therapy. Базовые параметры: от 20 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
Тайвань
Следующий шаг
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Официальное название

A Randomized, Open-label, Parallel-group Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in Early ER+/HER2- Breast Cancer

Обзор

The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer.

Подробное описание

The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer. We will collect tumor tissue, blood, and stool samples prospectively before treatment, at 2 weeks after treatment, and after 12 weeks of treatment at the time of surgery. Immune modulation effects will be compared between 3 treatment groups from breast tumor RNAseq analysis.

Вмешательства

  • Препарат Palbociclib
    CDK4, 6 inhibitor
  • Препарат Ribociclib
    CDK4, 6 inhibitor
  • Препарат Abemaciclib
    CDK4, 6 inhibitor
  • Препарат Letrozole
    Endocrine therapy

Первичные конечные точки

  • The expression of immune-related signature change after different CDK4/6 inhibitor treatments by RNAseq [Срок оценки: Through study completion, an average of 3 years]
Вторичные конечные точки (1)
  • Adverse events [Срок оценки: 4 months]

Критерии участия

Критерии включения

  • Female patients aged ≥ 20 years old at the time of informed consent.
  • Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. with estrogen receptor positive (>10%) on IHC staining and HER2 negative (IHC 0+/1+, or IHC 2+ plus FISH negative)
  • Stage II to III
  • With adequate organ function
  • ECOG 0-1

Критерии исключения

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential unless using highly effective methods of contraception during study drug dosing and for 12 months post-dosing
  • Patients with active systemic infections or known to have AIDS or to test positive for HIV antibody at Screening
  • Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Тайвань · 2 центра
  • Department of Oncology, National Taiwan University Hospital — Taipei
  • Department of Oncology,National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT05766410 · 202207200MIPB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗