Breast Cancer Clinical Trial
Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing
Summary
Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems.
The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.
Eligibility Criteria
Inclusion Criteria - Patients:
Diagnosis of metastatic or advanced resectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Tumor assessment by radiographic imaging will be performed within 4 weeks of baseline study visit.
Cohort 1 only: Scheduled to initiate standard of care first-line therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for the stated diagnosis at the time of study enrollment. Type of endocrine therapy and CDK 4/6 inhibitor will be documented.
Cohort 2 only: Currently receiving first-line therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for no longer than 24 months with at least stable disease (no progression) on such therapy for a minimum of 12 weeks prior to enrollment as determined by radiographic studies as deemed appropriate by the treating physician. Type of endocrine therapy and CDK 4/6 inhibitor will be documented.
Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.
Cohorts 1 and 2: Prior receipt of adjuvant CDK 4/6 inhibitor therapy is permitted provided therapy completion occurred > 12 months prior to study enrollment.
At least 18 years of age.
Life expectancy > 6 months.
Post-menopausal status, defined as one of the following:
Age ≥ 60 years
Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more
Status post bilateral oophorectomy, total hysterectomy
Pre- or peri-menopausal with suppressed ovarian function by use of GnRH agonist/antagonist or surgical bilateral oophorectomy
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Currently being treated at Siteman Cancer Center by a medical oncologist participating in this trial.
Exclusion Criteria - Patients:
Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.
A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.
Eligibility Criteria - Physicians:
Medical Oncologist at Siteman Cancer Center
Treating patients with metastatic or advanced unresectable invasive breast cancer
Willing to complete Study Care Plans on a serial basis during participation
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There is 1 Location for this study
Saint Louis Missouri, 63110, United States More Info
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