Ignite Creation Date:
2024-05-06 @ 12:27 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03769415
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2018-11-29
Brief Title:
Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
HARMONY Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
HARMONY
Brief Summary:
The HARMONY trial is an interventional trial enrolling metastatic breast cancer MBC Current treatment of breast cancer uses clinical subtype information eg hormone receptor-positive HR to help guide treatment options Breast cancer can also be characterized by molecular subtype but it is not known if this information is helpful in determining treatment when breast cancer has become metastatic HARMONY will give the treating physician of each participant the molecular subtype of the tumor based on PAM50 testing The usefulness of this information will be determined through the physician survey Finding out the molecular subtype of each tumor also allows the investigators to determine if the molecular subtype is different from what is expected based on the clinical subtype This study will help determine how new types of information about tumors can help choose treatments for MBC
Detailed Description:
Primary Objectives
1 To determine if clinical molecular subtypes differ from expected results 15 of the time
2 To determine if molecular information alters treatment plans as perceived by treating physicians through the survey
Subjects will be consented to the trial and archival tissue from the primary tumor will be obtained Stored tissue from metastatic sites will also be obtained The physician will be asked what the preferred medications are for the next two lines of treatment PAM50 testing to determine molecular subtypes will be determined on primary and metastatic tissue The molecular subtype results of the primary tissue will be returned to the physician and the physician will again be asked the preferred medications for the next two lines of treatment The number of times these medications change between the first and second surveys will be determined
Subjects active participation will only last as long as the consent process
1 To determine if clinical molecular subtypes differ from expected results 15 of the time
2 To determine if molecular information alters treatment plans as perceived by treating physicians through the survey
Subjects will be consented to the trial and archival tissue from the primary tumor will be obtained Stored tissue from metastatic sites will also be obtained The physician will be asked what the preferred medications are for the next two lines of treatment PAM50 testing to determine molecular subtypes will be determined on primary and metastatic tissue The molecular subtype results of the primary tissue will be returned to the physician and the physician will again be asked the preferred medications for the next two lines of treatment The number of times these medications change between the first and second surveys will be determined
Subjects active participation will only last as long as the consent process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None