Actively Recruiting
Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-30
500
Participants Needed
2
Research Sites
631 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
V
Veracyte, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or men at least 18 years of age
- Pathologically confirmed measurable or evaluable metastatic breast cancer with known ER, PR, and HER2 status from the primary tumor
- Enrolled before or during first line of metastatic treatment with no more than one prior metastatic therapy
- Accessible medical records for treatment and response data in metastatic setting
- Willing and able to receive medical treatment or follow-up at UNC-Chapel Hill
- Currently receiving treatment for metastatic breast cancer
- Treating physician considers patient well enough for standard care therapy including chemotherapy
- Willing to give blood for research at enrollment and at first disease progression
- Available archival primary tumor suitable for molecular analysis, or willing to obtain extra samples or biopsy for analysis
- Available archival metastatic sample suitable for molecular analysis, or willing to undergo biopsy for analysis; enrollment allowed if biopsy not possible
- Capable of providing informed consent and willing to participate in experimental trial
You will not qualify if you...
- No available or suitable tissue for molecular analysis or unwillingness to provide tissue for research during clinical procedure
- Dementia, altered mental status, or psychiatric/comorbid conditions preventing informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
2
UNC Rex Healthcare
Raleigh, North Carolina, United States, 27607
Actively Recruiting
Research Team
L
Lori Stravers
CONTACT
E
Erin Kelly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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