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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03769415
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Intrinsic Subtyping of Primary Breast Cancer — DEVICE
    Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype

Study Details

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

Key Dates

Start date
Nov 6, 2018
Status verified
Jan 2026
Primary completion
Dec 15, 2030
Completion
Dec 15, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intrinsic subtyping of Primary Breast Cancer
    Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined

Primary Outcome Measure

Change of treatment plan based on physician survey [ Time Frame: 4 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Erin Kelly, MPH, RD, LDN
[email protected]
919-966-0040
Terri Eubanks
[email protected]
9199664530
Lisa A Carey, MD (PRINCIPAL_INVESTIGATOR)
UNC Rex HealthcareRaleighNorth Carolina27607
Terri A Eubanks
[email protected]
919-966-4530
A
JoEllen Speca (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCUNC Rex Healthcare· Raleigh, NC

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