This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize (improve) these levels in patients with estrogen receptor (ER) or progesterone receptor (PR) positive, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and are receiving CDK 4/6 inhibitors. CDK4/6 inhibitors in combination with endocrine therapy (ET) is first line treatment for metastatic hormone positive (ER/PR positive) breast cancer (mBC). Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division). DiviTum-thymidine kinase activity (TKa) is a Food and Drug Administration approved assay which showed that a TKa is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. Using the DiviTum-TKa may improve medication compliance and remove potential drug-drug interactions in patients with ER/PR positive HER2-negative MBC.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize (improve) these levels in patients with estrogen receptor (ER) or progesterone receptor (PR) positive, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and are receiving CDK 4/6 inhibitors. CDK4/6 inhibitors in combination with endocrine therapy (ET) is first line treatment for metastatic hormone positive (ER/PR positive) breast cancer (mBC). Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division). DiviTum-thymidine kinase activity (TKa) is a Food and Drug Administration approved assay which showed that a TKa is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. Using the DiviTum-TKa may improve medication compliance and remove potential drug-drug interactions in patients with ER/PR positive HER2-negative MBC.
Tka Assay for CDK4/6i
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Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States, 06418
Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, United States, 06824
Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury, Connecticut, United States, 06033
Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States, 06830
Smilow Cancer Hospital Care Center - Guilford, Guilford, Connecticut, United States, 06437
Smilow Cancer Hospital-Hamden Care Center, Hamden, Connecticut, United States, 06518
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States, 06105
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital Saint Raphael Campus, New Haven, Connecticut, United States, 06511
Yale University, New Haven, Connecticut, United States, 06520
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
FEMALE
No
Yale University,
Mariya Rozenblit, PRINCIPAL_INVESTIGATOR, Yale University
2027-05-03