Breast CancerHARMONYNCT03769415
Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA
A study testing Intrinsic Subtyping of Primary Breast Cancer in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intrinsic Subtyping of Primary Breast Cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Nov 2018to 15 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Erin Kelly, MPH, RD, LDN, 919-966-0040, erin_kelly@med.unc.edu
Terri Eubanks, 9199664530, teubanks@med.unc.edu
- Recruiting
UNC Rex Healthcare
Raleigh, North Carolina, 27607
Terri A Eubanks, 919-966-4530, teubanks@med.unc.edu
A
About this study
Official title: HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer
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
Read the detailed description
Primary Objectives:
- To determine if clinical: molecular subtypes differ from expected results 15% of the time
- 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
- Being tested
- Intrinsic Subtyping of Primary Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsic Subtyping of Primary Breast CancerDevice
Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype
| Study group | Role | What they receive |
|---|---|---|
| Intrinsic subtyping of Primary Breast Cancer | Experimental | Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined Receives: Device: Intrinsic Subtyping of Primary Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of treatment plan based on physician survey
Number of times physicians change response to the question:" What are the preferred next 2 lines of treatment?" after knowledge of molecular subtype
Measured: 4 years
Overall rate of clinical:molecular primary tumor subtype incongruence
Number of times RNA-based molecular subtype differs from clinically determined subtype in primary breast tumors
Measured: 4 years
Secondary outcomes (6)
Intra-patient PFS ratio comparison
Number of days between initiation of therapy for each line and the date of progression or death (PFS) with adjustment for the expected PFS deterioration over lines of therapy
Measured: 4 years
Intra-patient PFS ratio separated by clinical subtype
Number of days between initiation of therapy for each line and the date of progression or death (PFS) with adjustment for the expected PFS deterioration over lines of therapy separated by each of the follow clinical subtypes: or HR+/HER2-, HR-/HER2+, HR+/HER2+ and HR-/HER2-
Measured: 4 years
Number of patients with HR+/HER2- MBC receiving endocrine therapy on each line of therapy
Number of patients with HR+/HER2- MBC receiving endocrine therapy based on medical record
Measured: 4 years
Rate of molecular discordance
Number of times molecular subtypes determined from primary tissue and molecular subtype determine from metastatic tissue are different
Measured: 4 year
PFS comparison in concordant therapy
PFS for patients receiving clinically-concordant therapy .
Measured: 4 years
PFS comparison in disconcordant therapy
PFS for patients receiving clinically-discordant therapy in congruent tumors
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start6 Nov 2018
- Primary completion15 Dec 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Veracyte, Inc., Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Lisa A Carey, MD, FASCO, ScM, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769415
- Sponsor's protocol ID
- LCCC1829
- Acronym
- HARMONY
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2018
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03769415
- Acronym / sponsor ID
- HARMONY / LCCC1829
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Veracyte, Inc., Breast Cancer Research Foundation
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine if clinical: molecular subtypes differ from expected results 15% of the time
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrinsic subtyping of Primary Breast Cancer | Experimental | Device: Intrinsic Subtyping of Primary Breast CancerIntrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrinsic Subtyping of Primary Breast CancerPrimary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype | Device | Intrinsic subtyping of Primary Breast Cancer |
Primary outcome
Change of treatment plan based on physician survey
Time frame: 4 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 incongruence
Time frame: 4 years
Number of times RNA-based molecular subtype differs from clinically determined subtype in primary breast tumors
6 secondary outcomes
Intra-patient PFS ratio comparison
Time frame: 4 years
Intra-patient PFS ratio separated by clinical subtype
Time frame: 4 years
Number of patients with HR+/HER2- MBC receiving endocrine therapy on each line of therapy
Time frame: 4 years
Rate of molecular discordance
Time frame: 4 year
PFS comparison in concordant therapy
Time frame: 4 years
PFS comparison in disconcordant therapy
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa A Carey, MD, FASCO, ScM principal investigator
UNC Lineberger Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrinsic Subtyping of Primary Breast Cancer in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Stravers (919-966-4432, lori_stravers@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of treatment plan based on physician survey (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.