Monitoring Breast Cancer Treatment with DiviTum® TKa
This study is looking at a new way to monitor treatment for metastatic breast cancer that is hormone receptor-positive (HR+) and HER2-negative. You would be receiving standard treatment with CDK 4/6 inhibitors. The study is testing if adding a blood test called DiviTum® TKa, which measures TK1 activity, helps doctors decide when to do other imaging tests. Doctors will record if they change their plans for your imaging tests after seeing the DiviTum® TKa results. The study aims to enroll 55 participants, but its current recruitment status is unclear. You may be eligible if you are 18 or older and have HR-positive, HER2-negative metastatic breast cancer.
- Study design
- This interventional study plans to enroll 55 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured within the first 48-week period of study participation.
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NCT04968964
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
Recruiting
NAAges 18+InterventionalHealth servicesWashington University School of MedicineInvestigator-initiated
~55 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:DiviTum® TKa assayStudy Care Plans
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value
Measured over Within the first 48-week period of study participation
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Nusayba Bagegni, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 combination 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. Patients may also be eligible if:
Patients were treated with and progressed on prior endocrine therapy monotherapy in the metastatic setting, OR
Patients initiated endocrine therapy alone with ultimate intention to add CDK 4/6 inhibitor therapy, OR
Patients recurred on adjuvant endocrine therapy monotherapy and are scheduled to receive next line endocrine therapy combined with CDK 4/6 inhibitor. Patients may have also received CDK 4/6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.
Cohort 2 only: Currently receiving first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib). Changes in endocrine therapy or CDK 4/6 inhibitor agent during first-line combination therapy are permitted as long as change was not performed due to progressive disease. CDK 4/6 inhibitor must have been initiated within 24 months of study enrollment, and patient must have 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. Patients may also be eligible if they are receiving next line endocrine therapy plus CDK 4/6 inhibitor therapy following:
Progression on prior endocrine therapy monotherapy in the metastatic setting, OR
Recurrence on adjuvant endocrine therapy monotherapy. Patients may have also received CDK 4/6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.
Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.
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
Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the protocol assessments or analyses are eligible for this trial as determined by treating physician and with agreement by Principal Investigator
Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.
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
What this trial measures
- Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa valueWithin the first 48-week period of study participation