Trastuzumab Rezetecan Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC

Официальное название

Trastuzumab Rezetecan Plus Pertuzumab as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Open-label, Phase II Trial

Обзор

This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.

Подробное описание

Patients with early-stage or locally advanced HER2-positive breast cancer were planned to be enrolled and subjected to neoadjuvant therapy with the regimen of Trastuzumab Rezetecan combined with Pertuzumab. The primary objective was to evaluate the efficacy and safety of Trastuzumab Rezetecan plus Pertuzumab as neoadjuvant treatment for early-stage or locally advanced HER2-positive breast cancer. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.

Вмешательства

• Препарат Trastuzumab Rezetecan
  Trastuzumab Rezetecan
• Препарат Pertuzumab
  Pertuzumab

Первичные конечные точки

• pCR rate [Срок оценки: At the time of surgery]

Вторичные конечные точки (4)

• iDFS [Срок оценки: Up to approximately 5 years]
• EFS [Срок оценки: Up to approximately 5 years]
• ORR [Срок оценки: Up to approximately 24 weeks after the first administration]
• AEs [Срок оценки: From the first dose until 30 days after last dose]

Критерии участия

Критерии включения

• Female patients aged 18-70 years;
• Histopathologically confirmed HER2 positive breast cancer;
• Patients were diagnosed with stage II-III breast cancer;
• At least one measurable target lesion according to RECIST V1.1;
• ECOG performance status score of 0 to 1;
• Life expectancy ≥12 weeks;
• Adequate bone marrow reserve and organ system function reserve;
• Participants should be able and willing to comply with the study protocol requirement;

Критерии исключения

• Breast cancer not histologically confirmed;
• Known inherited or acquired bleeding and thrombotic tendencies;
• Known allergy or contraindication to the study drug and its excipients;
• Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
• Concurrent receipt of any other form of anti-cancer therapy;
• History of a second primary malignancy, except for adequately treated skin cancer;
• Participation in other drug clinical trials within 4 weeks before enrollment;
• Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures;
• Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence;
• Uncontrolled or significant cardiovascular and cerebrovascular diseases;
• Subjects with known or suspected interstitial pneumonia;
• Presence of active hepatitis B, hepatitis C, liver cirrhosis;
• Pregnant or lactating female patients;
• History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.

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: NCT07047755 · HELEN-027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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