Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer

17 июня 2016 г. обновлено: Boehringer Ingelheim

An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer

The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

26

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
    • Victoria
      • East Bentleigh, Victoria, Австралия
        • 1200.89.61002 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Perth, Western Australia, Австралия
        • 1200.89.61003 Boehringer Ingelheim Investigational Site
  • Гонконг
      • Hong Kong, Гонконг
        • 1200.89.85201 Boehringer Ingelheim Investigational Site
  • Корея, Республика
      • Seoul, Корея, Республика
        • 1200.89.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Корея, Республика
        • 1200.89.82002 Boehringer Ingelheim Investigational Site
  • Соединенное Королевство
      • Bournemouth, Соединенное Королевство
        • 1200.89.44002 Boehringer Ingelheim Investigational Site
      • London, Соединенное Королевство
        • 1200.89.44001 Boehringer Ingelheim Investigational Site
      • London, Соединенное Королевство
        • 1200.89.44003 Boehringer Ingelheim Investigational Site
  • Соединенные Штаты
    • California
      • Los Angeles, California, Соединенные Штаты
        • 1200.89.10001 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Durham, North Carolina, Соединенные Штаты
        • 1200.89.10005 Boehringer Ingelheim Investigational Site
  • Таиланд
      • Bangkok, Таиланд
        • 1200.89.66002 Boehringer Ingelheim Investigational Site
      • Bangkok, Таиланд
        • 1200.89.66004 Boehringer Ingelheim Investigational Site
      • Chiangmai, Таиланд
        • 1200.89.66003 Boehringer Ingelheim Investigational Site
      • Hat-Yai, Songkhla, Таиланд
        • 1200.89.66001 Boehringer Ingelheim Investigational Site
  • Тунис
      • Ariana, Тунис
        • 1200.89.21601 Boehringer Ingelheim Investigational Site
      • Sousse, Тунис
        • 1200.89.21602 Boehringer Ingelheim Investigational Site

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Описание

Inclusion criteria:

  1. Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
  2. Locally advanced or metastatic disease
  3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
  4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
  5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer
  6. Must have biopsiable disease

Exclusion criteria:

  1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
  2. Must not have received prior vinorelbine treatment

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Afatinib once daily (OD)
Patients receive afatinib monotherapy once daily until progression of their disease
Лекарство: Afatinib once daily (OD)
Patient to receive afatinib monotherapy until progression of their disease
Лекарство: Vinorelbine Weekly
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Временное ограничение: This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Временное ограничение: This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Временное ограничение: This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
Objective response was defined on a patient level as a best response of CR or PR.
This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Временное ограничение: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
Objective response was defined on a patient level as a best response of CR or PR.
This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
Временное ограничение: This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
Objective response was defined on a patient level as a best response of CR or PR.
This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
Временное ограничение: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
Objective response was defined on a patient level as a best response of CR or PR.
This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
Part A: Duration of Unconfirmed Objective Response.
Временное ограничение: From first drug administration until end of Part A, up to 929 days.
Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).
From first drug administration until end of Part A, up to 929 days.
Part B: Duration of Unconfirmed Objective Response.
Временное ограничение: From first drug administration until end of Part B, up to 929 days.
Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).
From first drug administration until end of Part B, up to 929 days.
Part A: Progression Free Survival.
Временное ограничение: From first drug administration until end of Part A, up to 713 days.
PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A.
From first drug administration until end of Part A, up to 713 days.
Part B: Progression Free Survival.
Временное ограничение: From first drug administration until end of Part B, up to 230 days.
PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B.
From first drug administration until end of Part B, up to 230 days.
Progression Free Survival Over the Whole Sudy.
Временное ограничение: From first drug administration until end of study, up to 700 days.
PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.
From first drug administration until end of study, up to 700 days.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Boehringer Ingelheim

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 августа 2011 г.

Первичное завершение (Действительный)

1 ноября 2014 г.

Завершение исследования (Действительный)

1 ноября 2014 г.

Даты регистрации исследования

Первый отправленный

28 марта 2011 г.

Впервые представлено, что соответствует критериям контроля качества

28 марта 2011 г.

Первый опубликованный (Оценивать)

29 марта 2011 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

19 июля 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

17 июня 2016 г.

Последняя проверка

1 июня 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 1200.89
  • 2010-024454-10 (Номер EudraCT: EudraCT)

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться