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HARMONY Trial: Understanding Breast Cancer Subtypes in Metastatic Disease

The HARMONY trial is studying how different ways of classifying breast cancer might help doctors choose the best treatments for metastatic breast cancer (cancer that has spread). Currently, doctors use clinical information like whether the cancer is hormone receptor-positive (HR+) to guide treatment. This study will also look at the tumor's molecular subtype using a test called Nanostring PAM50 Testing. You might be able to join if you are at least 18 years old, have metastatic breast cancer, and are starting your first or second line of treatment. The study aims to see if molecular subtype information changes doctors' treatment plans and if the molecular subtype often differs from what's expected based on clinical information. This study is currently enrolling up to 500 participants.

Study design
This is an interventional study with an enrollment goal of 500 participants. It is not specified if it is randomized or blinded.
What's involved
Your active participation involves consenting to the trial. Archival tissue from your primary tumor and stored tissue from metastatic sites will be obtained.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes in treatment plans and the rate of subtype differences at 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03769415

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

Recruiting
NAAges 18–99InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~500 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:Intrinsic Subtyping of Primary Breast Cancer

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of treatment plan based on physician survey
Measured over 4 years
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

2 sites across 1 states
North Carolina2

Study leadership

  • Lisa A Carey, MD, FASCO, ScM · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Lori Stravers
[email protected]
919-966-4432
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 for metastatic breast cancer.
Treating physician considers patient well enough for standard of care therapy including chemotherapy.
Willing to give blood for research purposes upon study enrollment and at first disease progression.
Available archival primary tumor suitable for molecular analysis. If the primary is not available, willingness to obtain extra samples for research during planned standard of care biopsy, or willingness to undergo biopsy for repeat clinical receptors and molecular analyses.
Archival metastatic sample available and suitable for molecular analysis. If not available, willingness to undergo biopsy for repeat clinical receptors and molecular analyses. If no archival metastatic sample is available and the metastasis is not amenable to biopsy per treating physician the patient may still be enrolled.
Be willing and capable of providing informed consent, recognize the experimental nature of the trial, and sign the IRB-approved written informed consent documentations

Exclusion

Does not have tissue available or suitable for molecular analysis, or is unwilling to provide tissue for research at the time of a clinically indicated procedure.
Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.

What this trial measures

  • Change of treatment plan based on physician survey4 years

    Number of times physicians change response to the question:" What are the preferred next 2 lines of treatment?" after knowledge of molecular subtype

  • Overall rate of clinical:molecular primary tumor subtype incongruence4 years

    Number of times RNA-based molecular subtype differs from clinically determined subtype in primary breast tumors