Using molecular subtype analysis to improve treatment for metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The HARMONY trial focuses on patients with metastatic breast cancer, aiming to determine the impact of molecular subtype information on treatment decisions. Participants will undergo PAM50 testing to identify the molecular subtype of their tumors, and treating physicians will be surveyed to assess any changes in treatment plans based on this information. The study will compare the expected clinical subtypes with the actual molecular subtypes to evaluate discrepancies and their potential influence on therapy choices. This trial seeks to enhance personalized treatment strategies for metastatic breast cancer patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• UNC Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting
• UNC Rex Healthcare
  Raleigh, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Lisa A Carey, MD, FASCO, ScM — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Lori Stravers
• Email: lori_stravers@med.unc.edu
• Phone: 919-966-4432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.