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Molecular Subtyping for Metastatic Breast Cancer (HARMONY Trial)

N/A

Recruiting

Led By Lisa A Carey, MD, FASCO, ScM

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Enrolled before or during first line of treatment for metastatic breast cancer. No more than 1 prior line of therapy in the metastatic setting

Receiving treatment for metastatic breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 year

Awards & highlights

HARMONY Trial Summary

This trial is testing whether giving doctors information about the molecular subtype of a patient's metastatic breast cancer will help them choose more effective treatments.

Who is the study for?

The HARMONY trial is for men and women over 18 with metastatic breast cancer, who are well enough for standard treatments like chemo. They must have measurable cancer with known hormone receptor status, accessible medical records, and be in or starting their first line of treatment. Participants need to provide blood samples and a tumor biopsy if no suitable sample exists.Check my eligibility

What is being tested?

This study tests whether knowing the molecular subtype of a breast tumor (using PAM50 testing) helps doctors choose better treatments for metastatic breast cancer. It compares current clinical subtyping methods against additional molecular information to see if it changes treatment decisions.See study design

What are the potential side effects?

Since this trial involves standard care therapies which may include chemotherapy, side effects can range from fatigue, nausea, hair loss, increased risk of infection to more severe reactions depending on the specific drugs used.

HARMONY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in or before my first treatment for metastatic breast cancer, with no more than one prior therapy.

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I am currently being treated for breast cancer that has spread.

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My breast cancer has spread, and its hormone receptor status is known.

HARMONY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of treatment plan based on physician survey

Overall rate of clinical:molecular primary tumor subtype incongruence

Secondary outcome measures

Intra-patient PFS ratio comparison

Intra-patient PFS ratio separated by clinical subtype

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

+3 more

HARMONY Trial Design

1Treatment groups

Experimental Treatment

Group I: Intrinsic subtyping of Primary Breast CancerExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

87,833 Total Patients Enrolled

51 Trials studying Breast Cancer

27,486 Patients Enrolled for Breast Cancer

Veracyte, Inc.Industry Sponsor

3 Previous Clinical Trials

1,001,393 Total Patients Enrolled

Lisa A Carey, MD, FASCO, ScMPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Media Library

Intrinsic Subtyping of Primary Breast Cancer Clinical Trial Eligibility Overview. Trial Name: NCT03769415 — N/A

Breast Cancer Research Study Groups: Intrinsic subtyping of Primary Breast Cancer

Breast Cancer Clinical Trial 2023: Intrinsic Subtyping of Primary Breast Cancer Highlights & Side Effects. Trial Name: NCT03769415 — N/A

Intrinsic Subtyping of Primary Breast Cancer 2023 Treatment Timeline for Medical Study. Trial Name: NCT03769415 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment count for this experimental procedure?

"Indeed, the information available on clinicaltrials.gov suggests that this medical research is actively enrolling participants. The trial was originally put up on November 6th 2018 and has most recently been edited on 28th of November 2022. 500 patients need to be enrolled at 1 sites."

Answered by AI

To whom does eligibility for this trial extend?

"Eligible participants for this research trial must have a diagnosis of breast cancer and meet the age requirement between 18 to 999 years old. The study is expected to enroll around 500 patients."

Answered by AI

What are the essential goals of this examination?

"This 4 year clinical trial aims to determine changes in treatment approaches through physician survey results. Secondary objectives include evaluating progression-free survival (PFS) among patients receiving concordant and discordant therapies, as well as the number of hormone receptor positive/HER2 negative advanced breast cancer patients who are prescribed endocrine therapy depending on their medical record."

Answered by AI

Is this medical research currently seeking participants?

"This clinical trial is presently searching for suitable candidates. The original posting was on November 6th 2018, and the latest update to this medical study occurred on November 28th 2022."

Answered by AI