RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2018-11-06

Study Completion:2030-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03769415

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.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Lori Stravers

CONTACT

919-966-4432

lori_stravers@med.unc.edu

Erin Kelly

CONTACT

919-966-0040

erin_kelly@med.unc.edu

Principal Investigator

Lisa A Carey, MD, FASCO, ScM

PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

UNC Rex Healthcare

Raleigh, North Carolina, 27607

United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-06

Study Completion Date2030-12-15

Study Record Updates

Study Start Date2018-11-06

Study Completion Date2030-12-15

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer