Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428396
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-05-20
Brief Title:
Study of Belzutifan MK-6482 Plus Fulvestrant for ERHER2- Metastatic Breast Cancer MK-6482-029LITESPARK-029
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 2 Randomized Active-controlled Open-label Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy LITESPARK-029
Status:
NOT_YET_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:
None
Brief Summary:
The purpose of this study is to assess the efficacy and safety of belzutifan MK-6482 plus fulvestrant compared to everolimus plus endocrine therapy ET investigators choice of fulvestrant or exemestane in adults with estrogen receptor-positive human epidermal growth factor receptor 2-negative ERHER2- unresectable metastatic breast cancer There is no formal hypothesis testing in this study
Detailed Description:
None
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 |
|---|---|---|---|
| MK-6482-029 | OTHER | None | None |
| LITESPARK-029 | OTHER | Merck | None |