Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

Официальное название

A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy

Обзор

This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.

Подробное описание

This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.

Вмешательства

• Препарат Epirubicin or Pirarubicin
  Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d\*4cycls
• Препарат Cyclophosphamide
  Cyclophosphamide 600mg/m2 IV, q21d\*4cycls

Первичные конечные точки

• RFS [Срок оценки: median 5 years]

Вторичные конечные точки (3)

• OS [Срок оценки: median 5 years]
• Percentage of patients with adverse events [Срок оценки: 2-3 years]
• Changes in patient-reported quality of life [Срок оценки: 2-3 years]

Критерии участия

Критерии включения

• Patients with histologically confirmed invasive adenocarcinoma of the breast.
• Triple negative breast cancer: hormone receptor negative (ER < 10% and PgR < 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
• Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
• Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
• Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
• Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
• ECOG Performance Status: 0-1.
• Patients without severe heart, lung, liver and kidney disease.
• Adequate hematologic and end-organ function.
• No more than 6 weeks may elapse between definitive breast surgery and randomization.

Критерии исключения

• Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
• Previous neoadjuvant chemotherapy with platinum or taxanes alone.
• Patients have received other adjuvant therapy.
• Comprehensive medical examinations have revealed distant metastases before randomization.
• Patients who are not suitable for anthracycline evaluated by investigators.
• Prior history of other malignancy (except carcinoma in situ).

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

Китай · 1 центр

• Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS) — Пекин

Идентификаторы

NCT: NCT04437160 · LC2019L06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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