Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT06231693
Status:
TERMINATED
Last Update Posted:
2025-05-08
First Post:
2024-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to a realignment of strategic priorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE\<10%) metastatic HER2-Low breast cancer.
Detailed Description:
Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 74911423.1.1001.0071 | OTHER | Hospital Israelita Albert Einstein | View |