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Harnessing Analysis RNA expression and Molecular subtype to Optimize Novel TherapY MBCA

To determine if the clinical: molecular primary tumor subtype incongruent rate in metastatic breast cancer is greater than 15% (Objective 1a) and whether the results of a clinical RNA-based molecular subtyping assay alters treatment plans as perceived by the treating physician in at least 10% of metastatic breast cancer patients. This is a hybrid decentralized study where some if not all assessments may be performed close to your home.

Age & Gender

18 years ~ 99 years
Male, Female

Location

North Carolina (Statewide)

What will be asked of you

If you choose to take part in this study, some tumor tissue previously removed for standard of care purposes will be used for research. This study does not require a new biopsy. You will also be asked to provide blood samples during treatment visits. The amount of time needed is about 30 minutes at the time of consent. You may leave the study at any time.

Total length of participation:
Your participation will last about 30 minutes

Looking for Specific Volunteers

Able to participate:

Women or men at least 18 years of age
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.

Not eligible if:

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
Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.

Contact the Team

Visit Location

Lineberger Clinical Research

100% Remote (online, phone, text)

Additional Study Information

Principal Investigator

Lisa Carey
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

18-1352

ClinicalTrials.gov

NCT03769415

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Questions?

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