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Идёт набор NCT07124000

DESTINY-PANTUMOUR04

— Наблюдательное Adenocarcinoma (NOS) Anal Cancer Bladder Cancer Cervical 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: Trastuzumab deruxtecan.
Кому может быть актуально
Состояния в реестре: Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer. Базовые параметры: 18 лет — 130 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
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

Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study

Обзор

This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US

Подробное описание

This study is a multicenter, hybrid, observational study of approximately 100 prospectively enrolled patients with HER2-positive (IHC 3+) solid tumors in the US initiated on trastuzumab deruxtecan (T-DXd) as per FDA label in routine clinical practice and enrolled at the point of starting treatment with T-DXd. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options will be eligible for inclusion. Patients with breast, colorectal, non-small cell lung cancer (NSCLC), gastric/gastroesophageal junction (GEJ) cancers, and haematological malignancies are not eligible for this study.

Approximately 30 sites will be selected including community oncology practices, hospital systems and academic medical centers (AMCs), with a focus on enrolling a patient population representative of real-world care with the majority of patients from community settings. The primary objective of the study is to assess real world response rate and real world duration of response, and the secondary objective is to assess real world time to treatment discontinuation and real world time to next treatment.

Вмешательства

  • Препарат Trastuzumab deruxtecan
    Trastuzumab deruxtecan monotherapy

Первичные конечные точки

  • Real world response rate (rwRR) [Срок оценки: Through study completion, up to 2.5 years after enrolment]
  • Real world duration of response (rwDoR) [Срок оценки: Through study completion, up to 2.5 years after enrolment]
Вторичные конечные точки (2)
  • Real world time to treatment discontinuation (rwTTD) [Срок оценки: Through study completion, up to 2.5 years after enrolment]
  • Real world time to next treatment (rwTTNT) [Срок оценки: Through study completion, up to 2.5 years after enrolment]

Критерии участия

Критерии включения

  • Adults aged ≥18 years
  • Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);
  • A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;
  • HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;
  • Patients who are willing and able to provide a signed and dated informed consent.

Критерии исключения

  • Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;
  • Prior T-DXd therapy;
  • Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.
  • Patient is participating in a clinical trial at time of enrolment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 18 центров
  • Research Site — Birmingham
  • Research Site — Bullhead City
  • Research Site — Casa Grande
  • Research Site — San Diego
  • Research Site — Boulder
  • Research Site — Coral Springs
  • Research Site — St. Petersburg
  • Research Site — West Palm Beach
  • … и ещё 10 центров

Идентификаторы

NCT: NCT07124000 · D781WR00001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗