Ignite Creation Date:
2024-05-06 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05104866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2021-10-04
Brief Title:
A Phase-3 Open-Label Randomized Study of Dato-DXd Versus Investigators Choice of Chemotherapy ICC in Participants With Inoperable or Metastatic HR-Positive HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy TROPION-Breast01
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase-3 Open-Label Randomized Study of Dato-DXd Versus Investigators Choice of Chemotherapy ICC in Participants With Inoperable or Metastatic HR-Positive HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy TROPION-Breast01
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The study will evaluate the safety and efficacy of datopotamab deruxtecan also known as Dato-DXd DS-1062a when compared with Investigators choice of standard of care single-agent chemotherapy eribulin capecitabine vinorelbine or gemcitabine in participants with inoperable or metastatic HR-positive HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy
Detailed Description:
The primary objective of this study will assess the safety and efficacy of datopotamab deruxtecan Dato-DXd in participants with inoperable or metastatic HR-positive HER2-negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy
The study will be stratified based on number of previous lines of chemotherapy 1 vs 2 prior use of CDK46 inhibitors Yes vs no and geographic region of participant USCanadaEurope vs rest of world
This study aims to see if datopotamab deruxtecan allows patients to live longer without their breast cancer getting worse or simply to live longer compared to patients receiving standard of care chemotherapy This study is also looking to see how the treatment and the breast cancer affects patients quality of life
The study will be stratified based on number of previous lines of chemotherapy 1 vs 2 prior use of CDK46 inhibitors Yes vs no and geographic region of participant USCanadaEurope vs rest of world
This study aims to see if datopotamab deruxtecan allows patients to live longer without their breast cancer getting worse or simply to live longer compared to patients receiving standard of care chemotherapy This study is also looking to see how the treatment and the breast cancer affects patients quality of life
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005620-12 | EUDRACT_NUMBER | None | None |