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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 : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
The HAROMY trial is an interventional trial enrolling metastatic breast cancer (MBC). Current treatment of breast cancer uses clinical subtype information (e.g hormone receptor-postive (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 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

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Intrinsic Subtyping of Primary Breast Cancer Not Applicable

Detailed Description:

Primary Objectives:

  1. To determine if clinical:molecular subtypes differ from expected results 15% of time
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : November 2022
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. Overall rate of clinical:molecular primary tumor subtype incongruence [ Time Frame: 4 years ]
    Number of types RNA-based molecular subtype differs from clinically determined subtype in primary breast tumors


Secondary Outcome Measures :
  1. 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

  2. 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-

  3. 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

  4. 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

  5. PFS comparison in concordant therapy [ Time Frame: 4 years ]
    PFS for patients receiving clinically-concordant therapy .

  6. PFS comparison in disconcordant therapy [ Time Frame: 4 years ]
    PFS for patients receiving clinically-discordant therapy in congruent tumors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • ECOG Performance status 0-1. Participants must have estimated life expectancy > 12 weeks and be well enough according to their treating physician that they will receive at least 2 additional lines of anticancer therapy.
  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Kathryn Pietrosimone, PhD (919) 445-6375 kathryn_pietrosimone@med.unc.edu
Contact: Emily F Bell 919-966-4530 emily_bell@med.unc.edu

Locations
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United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kathryn M Pietrosimone    919-445-6375    kp@med.unc.edu   
Contact: Emily F Bell    9199664530    emily_bell@med.unc.edu   
Principal Investigator: Lisa A Carey, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03769415     History of Changes
Other Study ID Numbers: LCCC 1829
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases