HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer
UNC Lineberger Comprehensive Cancer Center
Summary
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
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 m…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Women or men at least 18 years of age * Pathologically documented diagnosis of measurable or evaluable metastatic breast cancer with known ER, PR, and HER2 status determined by the local laboratory on the primary tumor. * Enrolled before or during first line of treatment for metastatic breast cancer. No more than 1 prior line of therapy in the metastatic setting. * Accessible medical records for all treatment and response data in the metastatic setting. * Willing and able to receive medical treatment or follow up by investigators at UNC-Chapel Hill. * Receiving treatment…
Interventions
- DeviceIntrinsic Subtyping of Primary Breast Cancer
Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype
Locations (2)
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
- UNC Rex HealthcareRaleigh, North Carolina