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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The usefulness of this information will be determined through the physician survey."
  • "To determine if molecular information alters treatment plans, as perceived by treating physicians through the survey."
  • "The number of times these medications change between the first and second surveys will be determined."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The HARMONY study looks at whether testing a tumor’s genes with a test called PAM50 helps doctors choose treatment for breast cancer that has spread. It is for adults starting or receiving their first treatment for this cancer. Doctors will receive the test results and answer a survey about how useful they are.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with breast cancer that has spread and can be measured or checked. The original tumor’s hormone receptor and HER2 test results must be known.
  • Join before or during the first course of treatment for breast cancer that has spread, with no more than one prior course. You must be receiving treatment.
  • Have medical records available showing treatments and how the cancer responded after it spread.
  • Be willing and able to receive care or follow-up at UNC-Chapel Hill. Your doctor must consider you well enough for usual treatment, including chemotherapy.
  • Agree to give blood for research when you join and when the cancer first gets worse.
  • Have stored tissue from the original tumor that can be tested, or agree to have tissue collected during a planned biopsy or a new biopsy. A biopsy removes a small tissue sample.
  • Have stored tissue from a site where cancer has spread, or agree to a biopsy there. You may still join without this sample if your doctor says a biopsy cannot be done.
  • Be able to understand that this is research and sign a consent form agreeing to join.

Who can't join

  • You do not have tumor tissue available or suitable for testing, or you will not provide tissue for research during a medically needed procedure.
  • You have dementia, confusion, a mental health condition, or another illness that prevents you from understanding or giving consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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.

Study sites (2)

NC