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| Name | Class |
|---|---|
| Veracyte, Inc. | INDUSTRY |
| Breast Cancer Research Foundation | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrinsic subtyping of Primary Breast Cancer | Experimental | Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrinsic Subtyping of Primary Breast Cancer | Device | Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change 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 | 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 | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 years |
| Intra-patient PFS ratio separated by clinical subtype |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori Stravers | Contact | 919-966-4432 | lori_stravers@med.unc.edu | |
| Erin Kelly | Contact | 919-966-0040 | erin_kelly@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa A Carey, MD, FASCO, ScM | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| Clinical trials at UNC Lineberger | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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- |
| 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 | 4 years |
| Rate of molecular discordance | Number of times molecular subtypes determined from primary tissue and molecular subtype determine from metastatic tissue are different | 4 year |
| PFS comparison in concordant therapy | PFS for patients receiving clinically-concordant therapy . | 4 years |
| PFS comparison in disconcordant therapy | PFS for patients receiving clinically-discordant therapy in congruent tumors | 4 years |
| UNC Rex Healthcare | Recruiting | Raleigh | North Carolina | 27607 | United States |
|
| D017437 |
| Skin and Connective Tissue Diseases |