Status:
RECRUITING
Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Veracyte, Inc.
Breast Cancer Research Foundation
Conditions:
Breast Cancer
Eligibility:
All Genders
18-99 years
Phase:
NA
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 he...
Detailed Description
Primary Objectives: 1. To determine if clinical: molecular subtypes differ from expected results 15% of the time 2. To determine if molecular information alters treatment plans, as perceived by treat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03769415
Start Date
November 6 2018
End Date
December 15 2030
Last Update
January 28 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
2
UNC Rex Healthcare
Raleigh, North Carolina, United States, 27607