This trial will follow approximately 200 patients with HER2 negative (HER2- low or HER2-0)- (IHC<2+) MBC who are starting T-DXd. The study will test a newly developed test to measure HER2 protein on tumor cells using an antibody that 'lights up' when attached to HER2. The 'light' is called fluorescence. Cells with HER2 light up when viewed under a microscope with a special light. The fluorescence strength matches with the amount of HER2 protein on the breast cancer cell. We propose to prove this test works in patients with MBC that is HER2 low (IHC<2+) and who are beginning treatment with T-DXd. Each patient in this study will have their tumor tested using this new fluorescence test (Quantitative Immunofluorescence, or QIF). Patients will be followed for response to T-DXd. We will compare the QIF score with IHC score as they relate to patients who benefit from T-DXd.
If you are eligible for the QuantifyHER study, you will be asked to allow researchers to request a part of the tumor tissue removed during your biopsy for metastatic breast cancer confirmation. They may also request previous tumor samples if they showed HER2-negative (HER2- low or HER2-0)- (IHC<2+) disease. If no tumor sample is available, you will not be eligible. You will undergo routine imaging tests at time points determined by your treating physician, and the results will be shared with the study team. Quantitative Immunofluorescence (QIF) and a new mRNA expression test will be conducted on a portion of your tumor samples at Dr. Rimm's lab. The QIF test has been validated for consistent results. You will be asked if you want to receive the test results. Your breast cancer care will be managed by your oncologist, and you won't need to interact with the study team for direct care. No extra visits with the study team are required, except possibly for the initial enrollment. We also seek your permission to re-contact you for future research or questions that may arise during the study. If re-contacted, new research will be explained, and you can choose to participate. The researchers will protect your identifying information, such as your name or medical record number, during all research activities involving your samples.
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA
Yara Abdou
LCCC - Clinical Trials
Clinical or Medical
Observational
Cancer (Breast)
25-0147
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