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Идёт набор NCT06692725

De-escalation of Neoadjuvant Chemotherapy Regimens With Immunotherapy Among TNBC

— 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: Без ограничений · 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
Китай
Следующий шаг
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Официальное название

De-escalation of Neoadjuvant Chemotherapy Regimens (Taxane Plus Carboplatin Versus Taxane Plus Carboplatin Sequential Anthracycline) With Immunotherapy Among TNBC

Обзор

The traditional neoadjuvant therapy for triple negative breast cancer is based on anthracycline, paclitaxel and carboplatin. Nowadays, immunotherapy combined with chemotherapy has become a new standard treatment, which not only benefits from pathological complete response (pCR), but also benefits from long-term survival. The standard chemotherapy combined with immunotherapy scheme recommended by the guidelines is TCb-AC combined with pabolizumab, but the complex chemotherapy scheme has the defects of long cycle and large adverse reactions, and the scheme of chemotherapy reduction has been explored. This project plans to adopt an ambispective cohort study, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and retrospectively include the triple negative breast cancer patients with clinical stage T2 and above and/or lymph node positive who received neoadjuvant therapy (TCb-AC combined with immunotherapy, or TCb combined with immunotherapy) admitted to the center from January 1, 2019 to November 31, 2024. Patients of the same type from December 1, 2024 to December 31, 2028 were prospectively included. The efficacy and safety of different treatment regimens were compared.

Подробное описание

Investigators retrospectively recruited the triple negative breast cancer patients with clinical stage T2 and above and/or lymph node positive who received neoadjuvant therapy (TCb-AC combined with immunotherapy, TCb combined with immunotherapy, or TCb chemotherapy only) admitted to the center from January 1, 2019 to November 31, 2024. Patients of the same type from December 1, 2024 to December 31, 2028 were prospectively included. The efficacy and safety of different treatment regimens were compared.

Inclusion Criteria:

1. Patients with triple negative breast cancer diagnosed by biopsy in Peking University People's Hospital; 2. The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis); 3. Received treatment in our hospital and had hospitalization records; 4. Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion Criteria:

1. Lack of clinical and pathological data (such as imaging data and pathological data); 2. Patients with metastatic breast cancer or bilateral breast cancer; 3. At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy; 4. Receiving other regimens besides the established neoadjuvant regimens

Primary end point: pathology complete response

Первичные конечные точки

  • pathology complete response [Срок оценки: 6 months]
Вторичные конечные точки (4)
  • Invasive disease free survival [Срок оценки: 5 years]
  • Disease free survival [Срок оценки: 5 years]
  • Breast cancer specific survival [Срок оценки: 5 years]
  • Overall survival [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • 1\) Patients with triple negative breast cancer diagnosed by biopsy in Peking University People's Hospital;
  • 2\) The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
  • 3\) Received treatment in our hospital and had hospitalization records;
  • 4\) Has signed and agreed to participate in the PKUPH breast disease cohort study.

Критерии исключения

  • 1\) Lack of clinical and pathological data (such as imaging data and pathological data);
  • 2\) Patients with metastatic breast cancer or bilateral breast cancer;
  • 3\) At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
  • 4\) Receiving other regimens besides the established neoadjuvant regimens

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06692725 · PKUPH2024Z160

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗