Harnessing Analysis RNA Expression & Molecular Subtype to Optimize Novel

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03769415
Study type	Interventional
Source	UNC Lineberger Comprehensive Cancer Center
Contact	Lori Stravers
Phone	919-966-4432
Email	lori_stravers@med.unc.edu
Status	Recruiting
Phase	N/A
Start date	November 6, 2018
Completion date	December 15, 2030

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms