Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802759
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2021-03-15
Brief Title:
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With 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 Treatment Combinations in Patients With Breast Cancer MORPHEUS- BREAST CANCER
Status:
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:
This is a Phase IbII open-label multicenter randomized umbrella study in participants with breast cancer Cohort 1 will focus on participants with inoperable locally advanced or metastatic estrogen receptor ER-positive HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 46 inhibitor CDK46i eg palbociclib ribociclib abemaciclib in the first- or second-line setting Cohort 2 will focus on inoperable locally advanced or metastatic ER-positive HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies of which one was a trastuzumab-and-taxane-based systemic therapy including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy and one was a HER2-targeting antibody-drug conjugate ADC eg ado-trastuzumab emtansine or trastuzumab-deruxtecan or a HER2-targeting tyrosine kinase inhibitor TKI eg tucatinib lapatinib pyrotinib or neratinib The study is designed with the flexibility to open new treatment arms as new treatments become available close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity or modify the patient population During Stage 1 participants in each cohort will be randomly assigned to treatment arms Participants in the control or experimental arms who experience unacceptable toxicity disease progression as determined by the investigator according to RECIST v11 or loss of clinical benefit as determined by the investigator during Stage 1 will be given the option of receiving a different treatment combination during Stage 2 provided they meet eligibility criteria and a treatment arm is open for enrollment No Stage 2 treatment is currently 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 |
|---|---|---|---|
| 2020-004889-19 | EUDRACT_NUMBER | None | None |
| 2023-507495-48-00 | REGISTRY | None | None |