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

NCT03769415 | Recruiting DMC FDA Device

• 1 other identifier: LCCC1829
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  4 years

Secondary Outcomes (6)

• Intra-patient PFS ratio comparison

  4 years

• Intra-patient PFS ratio separated by clinical subtype

  4 years

• Number of patients with HR+/HER2- MBC receiving endocrine therapy on each line of therapy

  4 years

• Rate of molecular discordance

  4 year

• PFS comparison in concordant therapy

  4 years

Study Arms (1)

Intrinsic subtyping of Primary Breast Cancer

EXPERIMENTAL

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

Device: Intrinsic Subtyping of Primary Breast Cancer

Interventions

Intrinsic Subtyping of Primary Breast Cancer DEVICE

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

Intrinsic subtyping of Primary Breast Cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Veracyte, Inc.: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (2)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

UNC Rex Healthcare

Raleigh, North Carolina, 27607, United States

RECRUITING

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lisa A Carey, MD, FASCO, ScM

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Stravers

CONTACT

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

Erin Kelly

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 7, 2018
• Study Start: November 6, 2018
• Primary Completion (Estimated): December 15, 2030
• Study Completion (Estimated): December 15, 2030
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (2)