Идёт набор NCT07166185

Efficacy of Neoadjuvant Subcutaneous Trastuzumab-Pertuzumab in Algerian Women With Locally Advanced HER2 Positive Breast Cancer

— Наблюдательное Non Metastatic HER2 Positive 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: Non Metastatic HER2 Positive Breast Cancer. Базовые параметры: от 19 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: Algeria
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

Evaluation of the Efficacy of Subcutaneous Trastuzumab-Pertuzumab Combination in Neoadjuvant Treatment of Non-Metastatic HER2-Positive Breast Cancer in Algerian Women

Обзор

This study aims to find out how effective and well-tolerated the subcutaneous form of trastuzumab-pertuzumab (known as Phesgo) is when given before surgery (neoadjuvant treatment) to Algerian women with early stage, HER2-positive breast cancer. The study will take place in three oncology centers in Algeria (Blida, Aïn Defla, Médéa) and include around 70 adult women diagnosed with non-metastatic HER2-positive breast cancer. Participants will receive Phesgo along with standard chemotherapy over about 18 weeks, followed by surgery. The main goal is to measure how many women achieve complete destruction of invasive cancer in the breast and nearby lymph nodes (pathological complete response, pCR). We will also look at other outcomes such as how many women can keep their breast, any side effects, quality of life, satisfaction with treatment, and factors that might predict response. Results from this real-world study will help assess whether Phesgo can simplify treatment delivery, reduce hospital burden, and improve care access in Algeria where healthcare resources are often stretched.

Первичные конечные точки

Pathological Complete Response (pCR) Rate [Срок оценки: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.]

Вторичные конечные точки (4)

Breast-Conserving Surgery Rate [Срок оценки: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.]
Incidence of Adverse Events [Срок оценки: From first dose of study treatment until 30 days after last dose (approximately 20-22 weeks).]
Patient Satisfaction With Treatment [Срок оценки: Post-surgery (approximately 24-28 weeks after treatment initiation).]
Predictive Factors of Response [Срок оценки: From baseline to surgery (approximately 18-24 weeks after treatment initiation).]

Критерии участия

Критерии включения

Female participants aged 19 years or older.
Histologically confirmed HER2-positive breast cancer (by immunohistochemistry and/or in situ hybridization), non-metastatic.
Candidate for neoadjuvant therapy according to local clinical practice.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Left ventricular ejection fraction (LVEF) ≥ 50%.
Signed written informed consent.