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

NCT03769415 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-01-30

No results posted yet for this study

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

Interventions

DEVICE

Intrinsic Subtyping of Primary Breast Cancer

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

Sponsors & Collaborators

  • Veracyte, Inc.

    collaborator INDUSTRY

  • Breast Cancer Research Foundation

    collaborator OTHER

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2030-12-15
Completion
2030-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769415 on ClinicalTrials.gov