Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA (HARMONY)
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|ClinicalTrials.gov Identifier: NCT03769415|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : March 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Intrinsic Subtyping of Primary Breast Cancer||Not Applicable|
- To determine if clinical:molecular subtypes differ from expected results 15% of time
- To determine if molecular information alters treatment plans, as perceived by treating physican through survey
Subjects will be consented to the trial and archival tissue from primary tumor will be obtained. Stored tissue from metastatic sites will also be obtained. The physician will be asked what the preferred medications for next two lines of treatment. PAM50 testing to determine molecular subtype will be determined on primary and metastatic tissue. The molecular subtype results of the primary tissue will be returned to the physician, and the physician will again be asked the preferred medications for the next two lines of treatment. The number of times these medications change between the first and second surveys will be determined.
Subjects active participation will only last as long as the consent process.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||December 15, 2030|
|Estimated Study Completion Date :||December 15, 2030|
Experimental: Intrinsic subtyping of Primary Breast Cancer
Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined
Device: Intrinsic Subtyping of Primary Breast Cancer
Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype
- Change of treatment plan based on physician survey [ Time Frame: 4 years ]Number of times physicians change response to the question:" What are the preferred next 2 lines of treatment?" after knowledge of molecular subtype
- Overall rate of clinical:molecular primary tumor subtype incongruence [ Time Frame: 4 years ]Number of times RNA-based molecular subtype differs from clinically determined subtype in primary breast tumors
- Intra-patient PFS ratio comparison [ Time Frame: 4 years ]Number of days between initiation of therapy for each line and the date of progression or death (PFS) with adjustment for the expected PFS deterioration over lines of therapy
- Intra-patient PFS ratio separated by clinical subtype [ Time Frame: 4 years ]Number of days between initiation of therapy for each line and the date of progression or death (PFS) with adjustment for the expected PFS deterioration over lines of therapy separated by each of the follow clinical subtypes: or HR+/HER2-, HR-/HER2+, HR+/HER2+ and HR-/HER2-
- Number of patients with HR+/HER2- MBC receiving endocrine therapy on each line of therapy [ Time Frame: 4 years ]Number of patients with HR+/HER2- MBC receiving endocrine therapy based on medical record
- Rate of molecular discordance [ Time Frame: 4 year ]Number of times molecular subtypes determined from primary tissue and molecular subtype determine from metastatic tissue are different
- PFS comparison in concordant therapy [ Time Frame: 4 years ]PFS for patients receiving clinically-concordant therapy .
- PFS comparison in disconcordant therapy [ Time Frame: 4 years ]PFS for patients receiving clinically-discordant therapy in congruent tumors
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769415
|Contact: Terri A Eubanksemail@example.com|
|Contact: Erin Kellyfirstname.lastname@example.org|
|United States, North Carolina|
|UNC Lineberger Comprehensive Cancer Center||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Rebekah Craver 919-966-7490 Rebekah_Craver@med.unc.edu|
|Contact: Terri Eubanks 9199664530 email@example.com|
|Principal Investigator: Lisa A Carey, MD|
|Responsible Party:||UNC Lineberger Comprehensive Cancer Center|
|Other Study ID Numbers:||
|First Posted:||December 7, 2018 Key Record Dates|
|Last Update Posted:||March 23, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
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