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Набор скоро начнётся NCT05388500

Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C)

Фаза III С лечением 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
В протоколе указаны: Paclitaxel + Trastuzumab, Trastuzumab.
Кому может быть актуально
Состояния в реестре: HER2-positive Breast Cancer. Базовые параметры: от 18 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

Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy, a Randomised Comparison of Trastuzumab vs Trastuzumab+Paclitaxel in Women With HER2-positive Early Breast Cancer Receiving Neoadjuvant Treatment

Обзор

RATIONALE: According to previous results from PHARE study, a subgroup of patients with low-risk cancer (\< 3 cm) without axillary lymph node involvement or small (\< 2 cm) with minimal lymph node involvement (1 positive node) presented low risk of recurrence. Maintaining chemotherapy in this subgroup could cause toxicity and it is not yet known whether giving trastuzumab as monotherapy in neoadjuvant setting is as effective as giving trastuzumab combined with paclitaxel in patients with low risk early breast cancer. PURPOSE: This randomized phase III trial is studying trastuzumab as monotherapy in neoadjuvant setting to see if this treatment regimen is as efficient compared to trastuzumab combination with paclitaxel chemotherapy in treating women with low risk (tumor size\< 3 cm, N0) early breast cancer.

Подробное описание

PHARE-C is an open-label, randomized, phase III, non-inferiority trial, that will recruit patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer to allow for comparison of neoadjuvant treatment with paclitaxel plus trastuzumab versus trastuzumab as monotherapy.

Non-inferiority between the two treatment arms will be evaluated in terms of time to progression as primary objective. Treatment tolerance and cardiac toxicity will be assessed as secondary objectives.

In case of non pCR, a rescue by Trastuzumab emtansine (T-DM1) is planned to control the survival outcome.

Вмешательства

  • Препарат Paclitaxel + Trastuzumab
    Regarding neoadjuvant treatment : \- 9 to 12 weeks of neoadjuvant treatment Trastuzumab IV (8mg/kg loading dose followed by 6 mg/kg maintenance dose) or SubCutaneous (SC) (600mg fixed dose) every 3 weeks + weekly Paclitaxel IV : 80 to 90 mg/m2 Regarding adjuvant treatment patients will receive one of the following anti-HER2 therapy following the current standard to complete 1 year of anti-HER2 therapy in total : * in case of pCR : patient will receive trastuzumab * in case of non pCR : patien
  • Препарат Trastuzumab
    Regarding neoadjuvant treatment : \- 9 to 12 weeks of neoadjuvant treatment Trastuzumab IV (8mg/kg loading dose followed by 6 mg/kg maintenance dose) or SC (600mg fixed dose) every 3 weeks Regarding adjuvant treatment patients will receive one of the following anti-HER2 therapy following the current standard to complete 1 year of anti-HER2 therapy in total : * in case of pCR : patient will receive trastuzumab * in case of non pCR : patients will receive trastuzumab emtansine (T-DM1)

Первичные конечные точки

  • Time to progression [Срок оценки: up to 5 years]
Вторичные конечные точки (6)
  • Cardiac toxicity [Срок оценки: up to 5 years]
  • Treatment toxicity [Срок оценки: up to 5 years]
  • Total pathological Complete Response (tpCR) [Срок оценки: through surgery completion, an average of 12 weeks]
  • Breast pathological Complete Response (bpCR) [Срок оценки: through surgery completion, an average of 12 weeks]
  • Distant metastasis Free Survival [Срок оценки: up to 5 years]
  • Overall Survival [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

  • Histologically confirmed adenocarcinoma of the breast, nonmetastatic disease and non operated tumor
  • Without suspicious axillary nodes
  • Tumor size < 30 mm
  • Eligibility to receive a weekly paclitaxel based chemotherapy for this cancer
  • Left Ventricular Ejection Fraction (LVEF) obtained and > 50% as measured by echocardiography (Simpson method) or multigated acquisition scan (MUGA) at 3 months (-/+ 1 month)
  • Overexpression of HER-2 in the invasive component of the primary tumor as indicated by one of the following:

3+ by immunohistochemistry (IHC) 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)

  • With signed Informed consent

Критерии исключения

  • Previous anti-HER2 treatment (except for HERCEPTIN)
  • Cardiac disease or other medical conditions preventing trastuzumab administration
  • Known allergy to trastuzumab, murine proteins or other excipients
  • Pregnant or breastfeeding women
  • Patients that are not able to comply to the protocol assessments for geographic, social or psychological reasons

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
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05388500 · 2022-008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗