Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03424005
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2018-01-30
Brief Title:
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced 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 Metastatic Breast Cancer Morpheus-panBC
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:
Morpheus-panBC
Brief Summary:
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer
The study will be performed in two stages During Stage 1 four cohorts will be enrolled in parallel in this study
Cohort 1 will consist of Programmed death-ligand 1 PD-L1-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer TNBC first-line 1L PD-L1 cohort
Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy CIT second-line 2L CIT-naive cohort
Cohort 3 will consist of participants with locally-advanced or metastatic HR HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease HRcohort
Cohort 4 will consist of participants with locally-advanced or metastatic HER2 HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies HER2 HER2-low cohort
In each cohort eligible participants will initially be assigned to one of several treatment arms Stage 1 In addition participants in the 2L CIT-naïve cohort who experience disease progression loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination Stage 2 provided Stage 2 is open for enrollment
The study will be performed in two stages During Stage 1 four cohorts will be enrolled in parallel in this study
Cohort 1 will consist of Programmed death-ligand 1 PD-L1-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer TNBC first-line 1L PD-L1 cohort
Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy CIT second-line 2L CIT-naive cohort
Cohort 3 will consist of participants with locally-advanced or metastatic HR HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease HRcohort
Cohort 4 will consist of participants with locally-advanced or metastatic HER2 HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies HER2 HER2-low cohort
In each cohort eligible participants will initially be assigned to one of several treatment arms Stage 1 In addition participants in the 2L CIT-naïve cohort who experience disease progression loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination Stage 2 provided Stage 2 is open for enrollment
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 |
|---|---|---|---|
| 2017-002038-21 | EUDRACT_NUMBER | None | None |