A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
Фаза 3
Идёт, набор закрыт
NCT04739761
| Заболевание | Breast Cancer |
|---|
| Фаза | Фаза 3 |
|---|
| Спонсор | AstraZeneca |
|---|
| Статус | Идёт, набор закрыт |
|---|
| Участники | 506 участн. |
|---|
| Вмешательство | Trastuzumab Deruxtecan |
|---|
| Дата начала | 22.06.2021 |
|---|
| Дата завершения | 8.02.2024 |
|---|
| Публикация результатов | 16.05.2025 |
|---|
Кратко
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline)
From first dose (Day 1) to progression of disease (up to 2 years 7 months) · Percentage of participants
| Cohort 1: Trastuzumab Deruxtecan (T-DXd) | 62.7 Percentage of participants |
|---|
Progression-free Survival (PFS) Rate at 12 Months in Cohort 2 (Participants With Brain Metastasis at Baseline)
At 12 months · Percentage of participants
| Cohort 2: Trastuzumab Deruxtecan (T-DXd) | 61.6 Percentage of participants |
|---|
Открыть в BENITIONS
Открыть на ClinicalTrials.gov
Все исследования
Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.