Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 9:24 PM
Study NCT ID:
NCT04132960
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2019-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis
Sponsor:
UNICANCER
Organization:
Study Overview
Official Title:
Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAISY
Brief Summary:
Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer.
Detailed Description:
The main objective is to evaluate the anti-tumor activity of DS-8201a in three cohorts of advanced breast cancer patients:
* Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+)
* Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-)
* Cohort 3: HER2 non-expressing (IHC0+)
* Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+)
* Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-)
* Cohort 3: HER2 non-expressing (IHC0+)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-004868-57 | EUDRACT_NUMBER | None | View |