HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
UNC Rex Healthcare
RECRUITING
Raleigh
Contact Information
Primary
Lori Stravers
lori_stravers@med.unc.edu
919-966-4432
Backup
Erin Kelly
erin_kelly@med.unc.edu
919-966-0040
Time Frame
Start Date: 2018-11-06
Estimated Completion Date: 2030-12-15
Participants
Target number of participants: 500
Treatments
Experimental: Intrinsic subtyping of Primary Breast Cancer
Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined
Related Therapeutic Areas
Sponsors
Collaborators: Breast Cancer Research Foundation, Veracyte, Inc.
Leads: UNC Lineberger Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov