The HARMONY trial is an interventional trial enrolling metastatic breast cancer (MBC). Current treatment of breast cancer uses clinical subtype information (e.g. 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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
RECRUITINGUNC Rex Healthcare
Raleigh, North Carolina, United States
RECRUITINGChange of treatment plan based on physician survey
Number of times physicians change response to the question:" What are the preferred next 2 lines of treatment?" after knowledge of molecular subtype
Time frame: 4 years
Overall rate of clinical:molecular primary tumor subtype incongruence
Number of times RNA-based molecular subtype differs from clinically determined subtype in primary breast tumors
Time frame: 4 years
Intra-patient PFS ratio comparison
Number of days between initiation of therapy for each line and the date of progression or death (PFS) with adjustment for the expected PFS deterioration over lines of therapy
Time frame: 4 years
Intra-patient PFS ratio separated by clinical subtype
Number of days between initiation of therapy for each line and the date of progression or death (PFS) with adjustment for the expected PFS deterioration over lines of therapy separated by each of the follow clinical subtypes: or HR+/HER2-, HR-/HER2+, HR+/HER2+ and HR-/HER2-
Time frame: 4 years
Number of patients with HR+/HER2- MBC receiving endocrine therapy on each line of therapy
Number of patients with HR+/HER2- MBC receiving endocrine therapy based on medical record
Time frame: 4 years
Rate of molecular discordance
Number of times molecular subtypes determined from primary tissue and molecular subtype determine from metastatic tissue are different
Time frame: 4 year
PFS comparison in concordant therapy
PFS for patients receiving clinically-concordant therapy .
Time frame: 4 years
PFS comparison in disconcordant therapy
PFS for patients receiving clinically-discordant therapy in congruent tumors
Time frame: 4 years
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