Recruiting

Novel Therapy

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT03769415

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intrinsic Subtyping of Primary Breast Cancer

Study Details

Brief 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

Conditions

Breast Cancer

Study ID

NCT03769415

Start date

Nov 6, 2018

Status verified date

Jan, 2026

Completion date

Dec 15, 2030

Anticipated

Primary completion date

Dec 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intrinsic subtyping of Primary Breast Cancer

Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined

Interventions

Intrinsic Subtyping of Primary Breast Cancer

Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype

Primary outcome measure

  • Change of treatment plan based on physician survey [ Time Frame: 4 years ]
  • Overall rate of clinical:molecular primary tumor subtype incongruence [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Lori Stravers

919-966-4432lori_stravers@med.unc.edu

Erin Kelly

919-966-0040erin_kelly@med.unc.edu

Locations

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Erin Kelly, MPH, RD, LDN

919-966-0040erin_kelly@med.unc.edu

Terri Eubanks

9199664530teubanks@med.unc.edu

Principal Investigator:

Lisa A Carey, MD

UNC Rex Healthcare

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Terri A Eubanks

919-966-4530teubanks@med.unc.edu

Principal Investigator:

JoEllen Speca

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-01-30.