Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02213744
Status:
TERMINATED
Last Update Posted:
2017-01-06
First Post:
2014-08-06
Brief Title:
MM-302 Plus Trastuzumab vs Chemotherapy of Physicians Choice Plus Trastuzumab in HER2-Positive Locally AdvancedMetastatic Breast Cancer Patients
Sponsor:
Merrimack Pharmaceuticals
Organization:
Merrimack Pharmaceuticals
Study Overview
Official Title:
A Randomized Multicenter Open Label Study of MM-302 Plus Trastuzumab vs Chemotherapy of Physicians Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally AdvancedMetastatic HER2-Positive Breast Cancer
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Felt not to show benefit over control per DMC and confirmed via futility analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERMIONE
Brief Summary:
This study is an open label randomized multicenter trial of MM-302 plus trastuzumab The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physicians choice CPC plus trastuzumab in locally advancedmetastatic HER2-positive breast cancer patients Patients may not have been previously treated with an anthracycline in any setting Patients must have received prior treatment with trastuzumab in any setting have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None