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

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intrinsic Subtyping of Primary Breast Cancer

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UNC Lineberger Comprehensive Cancer CenterRecruiting
UNC Rex HealthcareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrinsic subtyping of Primary Breast Cancer

Arm Description

Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined

Outcomes

Primary Outcome Measures

Change of treatment plan based on physician survey

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

Number of times RNA-based molecular subtype differs from clinically determined subtype in primary breast tumors

Secondary Outcome Measures

Intra-patient PFS ratio comparison

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

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

Number of patients with HR+/HER2- MBC receiving endocrine therapy based on medical record

Rate of molecular discordance

Number of times molecular subtypes determined from primary tissue and molecular subtype determine from metastatic tissue are different

PFS comparison in concordant therapy

PFS for patients receiving clinically-concordant therapy .

PFS comparison in disconcordant therapy

PFS for patients receiving clinically-discordant therapy in congruent tumors

Full Information

NCT ID

NCT03769415

First Posted

November 29, 2018

Last Updated

September 28, 2023

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Veracyte, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03769415

Brief Title

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

Acronym

HARMONY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 6, 2018 (Actual)

Primary Completion Date

December 15, 2030 (Anticipated)

Study Completion Date

December 15, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Veracyte, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

Primary Objectives: To determine if clinical: molecular subtypes differ from expected results 15% of the time To determine if molecular information alters treatment plans, as perceived by treating physicians through the survey. Subjects will be consented to the trial and archival tissue from the primary tumor will be obtained. Stored tissue from metastatic sites will also be obtained. The physician will be asked what the preferred medications are for the next two lines of treatment. PAM50 testing to determine molecular subtypes 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intrinsic subtyping of Primary Breast Cancer

Arm Type

Experimental

Arm Description

Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined

Intervention Type

Device

Intervention Name(s)

Intrinsic Subtyping of Primary Breast Cancer

Intervention Description

Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype

Primary Outcome Measure Information:

Title

Change of treatment plan based on physician survey

Description

Number of times physicians change response to the question:" What are the preferred next 2 lines of treatment?" after knowledge of molecular subtype

Time Frame

4 years

Title

Overall rate of clinical:molecular primary tumor subtype incongruence

Description

Number of times RNA-based molecular subtype differs from clinically determined subtype in primary breast tumors

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Intra-patient PFS ratio comparison

Description

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

Time Frame

4 years

Title

Intra-patient PFS ratio separated by clinical subtype

Description

Time Frame

4 years

Title

Number of patients with HR+/HER2- MBC receiving endocrine therapy on each line of therapy

Description

Number of patients with HR+/HER2- MBC receiving endocrine therapy based on medical record

Time Frame

4 years

Title

Rate of molecular discordance

Description

Number of times molecular subtypes determined from primary tissue and molecular subtype determine from metastatic tissue are different

Time Frame

4 year

Title

PFS comparison in concordant therapy

Description

PFS for patients receiving clinically-concordant therapy .

Time Frame

4 years

Title

PFS comparison in disconcordant therapy

Description

PFS for patients receiving clinically-discordant therapy in congruent tumors

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lori Stravers

Phone

919-966-4432

lori_stravers@med.unc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Erin Kelly

Phone

919-966-0040

erin_kelly@med.unc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa A Carey, MD, FASCO, ScM

Organizational Affiliation

UNC Lineberger Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Lineberger Comprehensive Cancer Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebekah Craver

Phone

919-966-7490

Rebekah_Craver@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Terri Eubanks

Phone

9199664530

teubanks@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Lisa A Carey, MD

Facility Name

UNC Rex Healthcare

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Terri A Eubanks

Phone

919-966-4530

teubanks@med.unc.edu

First Name & Middle Initial & Last Name & Degree

JoEllen Speca

12. IPD Sharing Statement

Links:

URL

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

Description

Clinical trials at UNC Lineberger

Learn more about this trial

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

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