Using molecular subtype analysis to improve treatment for metastatic breast cancer
HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer
This study is testing if knowing the specific type of breast cancer at a molecular level can help doctors make better treatment choices for patients with metastatic breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT03769415 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with a documented diagnosis of metastatic breast cancer who are beginning or currently receiving their first line of treatment.
Not a fit: Patients who have already received multiple lines of therapy for metastatic breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and effective treatment options for patients with metastatic breast cancer.
How similar studies have performed: Other studies have shown promise in using molecular subtyping to guide treatment decisions, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chapel Hill, North Carolina and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.