Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03280563
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2017-09-11
Brief Title:
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor HR-Positive Human Epidermal Growth Factor Receptor 2 HER2-Negative Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase IbII Open-Label Multicenter Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer MORPHEUS-HR Breast Cancer
Status:
COMPLETED
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:
MORPHEUS HRBC
Brief Summary:
This study is designed to evaluate the efficacy safety and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase CDK 46 inhibitor in the first- or second-line setting such as palbociclib ribociclib or abemaciclib The study will be performed in two stages During Stage 1 participants will be randomized to fulvestrant control or an atezolizumab-containing doublet or triplet combination Those who experience disease progression loss of clinical benefit or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity New treatment arms may be added andor existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available
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 |
|---|---|---|---|
| 2017-000335-14 | EUDRACT_NUMBER | None | None |