NCT03769415

Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA

HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Intrinsic Subtyping of Primary Breast Cancer	Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype

Timeline

• Start date: 2018-11-06
• Primary completion: 2030-12-15
• Completion: 2030-12-15
• First posted: 2018-12-07
• Last updated: 2026-01-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study