Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03769415




Registration number
NCT03769415
Ethics application status
Date submitted
29/11/2018
Date registered
7/12/2018
Date last updated
1/10/2024

Titles & IDs
Public title
Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA
Scientific title
HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer
Secondary ID [1] 0 0
LCCC1829
Universal Trial Number (UTN)
Trial acronym
HARMONY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Intrinsic Subtyping of Primary Breast Cancer

Experimental: Intrinsic subtyping of Primary Breast Cancer - Intrinsic subtype of primary breast tissue from metastatic breast cancer subject will be determined


Treatment: Devices: Intrinsic Subtyping of Primary Breast Cancer
Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change of treatment plan based on physician survey
Timepoint [1] 0 0
4 years
Primary outcome [2] 0 0
Overall rate of clinical:molecular primary tumor subtype incongruence
Timepoint [2] 0 0
4 years
Secondary outcome [1] 0 0
Intra-patient PFS ratio comparison
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Intra-patient PFS ratio separated by clinical subtype
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Number of patients with HR+/HER2- MBC receiving endocrine therapy on each line of therapy
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Rate of molecular discordance
Timepoint [4] 0 0
4 year
Secondary outcome [5] 0 0
PFS comparison in concordant therapy
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
PFS comparison in disconcordant therapy
Timepoint [6] 0 0
4 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2030
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
UNC Lineberger Comprehensive Cancer Center
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Veracyte, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT03769415
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Lisa A Carey, MD, FASCO, ScM
Address 0 0
UNC Lineberger Comprehensive Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lori Stravers
Address 0 0
Country 0 0
Phone 0 0
919-966-4432
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03769415