Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04494425
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2020-07-20
Brief Title:
Study of Trastuzumab Deruxtecan T-DXd vs Investigators Choice Chemotherapy in HER2-low Hormone Receptor Positive Metastatic Breast Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 3 Randomized Multi-center Open-label Study of Trastuzumab Deruxtecan T-DXd Versus Investigators Choice Chemotherapy in HER2-Low Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting DESTINY-Breast06
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
DB-06
Brief Summary:
This study will evaluate the efficacy safety and tolerability of trastuzumab deruxtecan compared with investigators choice chemotherapy in human epidermal growth factor receptor HER2-low hormone receptor HR positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting
Detailed Description:
Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease or disease progression within 6 months of starting first line treatment for metastatic disease with an endocrine therapy combined with a CDK46 inhibitor All patients must have historically confirmed HR positive either estrogen receptor andor progesterone receptor positive HER2-low defined as IHC2ISH- and IHC 1 or HER2 IHC 0 1 expression as determined by central laboratory testing results advanced or metastatic breast cancer
The study aims to evaluate the efficacy safety and tolerability of trastuzumab deruxtecan compared with investigators choice chemotherapy This study aims to see if trastuzumab deruxtecan allows patients to live longer without the 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 cancer affects patients quality of life
The study aims to evaluate the efficacy safety and tolerability of trastuzumab deruxtecan compared with investigators choice chemotherapy This study aims to see if trastuzumab deruxtecan allows patients to live longer without the 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 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 |
|---|---|---|---|
| 2019-004493-26 | EUDRACT_NUMBER | None | None |