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Набор скоро начнётся NCT07129187

SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response

Фаза II С лечением Early Breast Cancer HER2 + Breast Cancer Stage II Breast Cancer Stage III 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: SHR-A1811.
Кому может быть актуально
Состояния в реестре: Early Breast Cancer, HER2 + Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer. Базовые параметры: 18 лет — 70 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
Список центров уточняется — проверьте первичный протокол.
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

An Open-label, Single-arm, Multicenter Study of SHR-A1811 as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients With Suboptimal Neoadjuvant Response

Обзор

This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.

Подробное описание

Patients will receive SHR-A1811, until completion or treatment discontinuation due to progression, toxicity, or withdrawal. The primary endpoint is tpCR (ypT0/is ypN0). Secondary endpoints include bpCR, RCB, EFS, and safety. The study will recruit 30 eligible patients from multiple centers in China.

Вмешательства

  • Препарат SHR-A1811
    Drug: SHR-A1811 4.8mg/kg

Первичные конечные точки

  • tpCR [Срок оценки: immediately after surgery]
Вторичные конечные точки (3)
  • Breast Pathological Complete Response [Срок оценки: immediately after surgery]
  • event free survival [Срок оценки: until the end of the study]
  • residual cancer burden [Срок оценки: immediately after surgery]

Критерии участия

Критерии включения

  • 1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;
  • 2.Early or locally advanced HER2-positive invasive breast cancer;
  • 3.Known hormone receptor status;
  • 4.ECOG score of 0-1;
  • 5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;
  • 6.Organ function levels must meet the following requirements:
  • 7.Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study and within 3 months after the last administration of the study drug.
  • 8.The subjects voluntarily participate in this study and sign the informed consent form.

Критерии исключения

  • 1\. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer
  • 2\. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention
  • 3\. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history
  • 4\. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)
  • 5\. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)
  • 6\. Interstitial lung disease, non-infectious pneumonia, uncontrolled systemic diseases
  • 7\. History of or planned administration of live attenuated vaccines within 28 days
  • 8\. HIV infection, active hepatitis (hepatitis B, hepatitis C, etc.), autoimmune hepatitis
  • 9\. Severe infection within 4 weeks, CTCAE grade ≥ 2 active infection within 2 weeks (except neoplastic fever), or evidence of active tuberculosis within 1 year
  • 10\. History of allogeneic bone marrow or solid organ transplantation
  • 11\. Peripheral neuropathy of grade ≥ 2
  • 12\. Severe heart diseases
  • 13\. Receipt of systemic immunostimulant therapy within 4 weeks
  • 14\. Receipt of systemic immunosuppressant therapy within 2 weeks (except local or physiological dose of hormones)
  • 15\. Allergy to study drugs/excipients, or history of severe allergic reaction to other monoclonal antibodies
  • 16\. Pregnant or lactating women; fertile women with positive pregnancy test or unwilling to take effective contraception throughout the trial
  • 17\. History of neurological/psychiatric disorders , or history of substance abuse, alcoholism, or drug addiction
  • 18\. Other circumstances deemed unsuitable for enrollment by the researcher

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07129187 · MA-BC-II-124

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗