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NCT03769415Recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
29 Nov 2018
Start date
Nov 2018
Primary completion date
Dec 2030
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
NCT number
NCT03769415

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From Nov 2018 to the primary completion date, Dec 2030
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UNC Lineberger Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
UNC Rex Healthcare
Coordinator of this site? Confirm its status
RaleighUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.