Breast CancerNCT04968964
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
A study testing DiviTum® TKa assay and Study Care Plans in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cancer of the Breast
- What is being tested?
- DiviTum® TKa assay and Study Care Plans
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Nusayba Bagegni, M.D., 314-273-3022, nbagegni@wustl.edu
Nusayba Bagegni, M.D.
About this study
Official title: TK IMPACT: 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: Physician Decision Impact Study
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.
- Conditions
- Breast Cancer, Cancer of the Breast
- Being tested
- DiviTum® TKa assay, Study Care Plans
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiviTum® TKa assayDevice
-Determines serum enzymatic activity of TK1
Study Care PlansOther
-Study Care Plans will be completed prior to and post release of serum DiviTum® TKa value
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Scheduled to receive first line therapy | Experimental | * Scheduled to receive 1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor
* Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient \& review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes Receives: Device: DiviTum® TKa assay |
| Cohort 2: Currently receiving first line therapy | Experimental | * 1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor for ≤ 24 months with stable disease
* Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient \& review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes Receives: Device: DiviTum® TKa assay |
| Medical Oncologists | Experimental | -Will be completing the Study Care Forms at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Receives: Other: Study Care Plans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value
Measured: Within the first 48-week period of study participation
Secondary outcomes (5)
Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values
Measured: At 12 weeks
Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values
Measured: At 12 weeks and 24 weeks
Number of surveillance imaging tests intended to be used and actually used, in total and by modality
Measured: Over the entire study period (estimated to be 36 months)
Longitudinal changes in DiviTum® TKa value dynamics
The TK trajectory of a patients will be plot against time for temporal pattern and the trajectories will be modeled via linear or non-linear mixed effects mode as appropriate. If linear mixed effects model, the longitudinal rate of change will be estimated with 95% CI to indicate growth rate of TK. If non-linear, the regression coefficients of time or time relevant terms will be estimated with 95% CI
Measured: Over the entire study period (estimated to be 36 months)
Cohort 1 only: DiviTum® TKa level
Measured: At 2 weeks post CDK 4/6 inhibitor therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start7 Mar 2022
- Primary completion1 Aug 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Biovica
- Responsible party
- Sponsor
- Investigators
- Nusayba Bagegni, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968964
- Sponsor's protocol ID
- 202107015
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TK IMPACT: 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: Physician Decision Impact Study
- ClinicalTrials.gov ID
- NCT04968964
- Acronym / sponsor ID
- 202107015
- Conditions
- Breast Cancer, Cancer of the Breast
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Biovica
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Scheduled to receive first line therapy | Experimental | Device: DiviTum® TKa assay* Scheduled to receive 1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor * Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient \& review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes |
| Cohort 2: Currently receiving first line therapy | Experimental | Device: DiviTum® TKa assay* 1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor for ≤ 24 months with stable disease * Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient \& review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes |
| Medical Oncologists | Experimental | Other: Study Care Plans-Will be completing the Study Care Forms at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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:
- Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.
- At least 18 years of age.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiviTum® TKa assay-Determines serum enzymatic activity of TK1 | Device | Cohort 1: Scheduled to receive first line therapy, Cohort 2: Currently receiving first line therapy |
| Study Care Plans-Study Care Plans will be completed prior to and post release of serum DiviTum® TKa value | Other | Medical Oncologists |
Primary outcome
Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value
Time frame: Within the first 48-week period of study participation
5 secondary outcomes
Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values
Time frame: At 12 weeks
Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values
Time frame: At 12 weeks and 24 weeks
Number of surveillance imaging tests intended to be used and actually used, in total and by modality
Time frame: Over the entire study period (estimated to be 36 months)
Longitudinal changes in DiviTum® TKa value dynamics
Time frame: Over the entire study period (estimated to be 36 months)
Cohort 1 only: DiviTum® TKa level
Time frame: At 2 weeks post CDK 4/6 inhibitor therapy initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nusayba Bagegni, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiviTum® TKa assay and Study Care Plans in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nusayba Bagegni, M.D. (314-273-3022, nbagegni@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value (time frame: Within the first 48-week period of study participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.