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

Description

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

Study Overview

Study Details

Study overview

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

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States, 27599

Raleigh

UNC Rex Healthcare, Raleigh, North Carolina, United States, 27607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UNC Lineberger Comprehensive Cancer Center,

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

Study Record Dates

2030-12-15